[Federal Register Volume 79, Number 31 (Friday, February 14, 2014)]
[Rules and Regulations]
[Pages 8832-8855]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03279]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 803

[Docket No. FDA-2008-N-0393]
RIN 0910-AF86


Medical Device Reporting: Electronic Submission Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is revising its 
postmarket medical device reporting regulation and making technical 
corrections. This final rule requires device manufacturers and 
importers to submit mandatory reports of individual medical device 
adverse events, also known as medical device reports (MDRs), to the 
Agency in an electronic format that FDA can process, review, and 
archive. Mandatory electronic reporting will improve the Agency's 
process for collecting and analyzing postmarket medical device adverse 
event information. Electronic reporting is also available to user 
facilities, but this rule permits user facilities to continue to submit 
written reports to FDA. This final rule also identifies changes to the 
content of required MDRs to reflect reprocessor information collected 
on the Form FDA 3500A as required by the Medical Device User Fee and 
Modernization Act of 2002 (MDUFMA).

DATES: This final rule is effective August 14, 2015 (see also section 
IX of this document).

FOR FURTHER INFORMATION CONTACT: Sharon E. Kapsch, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3208, Silver Spring, MD 20993-0002, 301-
796-6104.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. History of the Medical Device Reporting Regulation
II. Overview of the Final Rule
    A. Changes to the 2009 Proposed Rule
    B. Highlights of the Final Rule
    C. How do I submit MDRs in electronic format?
    D. How have the MDR requirements changed?
III. Comments on the Proposed Rule
    A. General
    B. Submitting Initial and Supplemental or Followup Reports 
(Sec.  803.12(a))
    C. Establishing and Maintaining MDR Records (Sec.  803.18)
    D. Copies Kept in MDR Files of All Reports Submitted (Sec.  
803.18(b)(1)(ii))
    E. Copies of All Electronic Acknowledgments (Sec.  
803.18(b)(1)(iii))
    F. Manufacturer Reporting Requirements (Sec.  803.50(a))
    G. Report Date (Sec.  803.52(b)(4))
    H. Product Code and Common Device Name (Sec.  803.52(c)(2))
    I. Name and Address of the Reprocessor (Revised Sec.  
803.52(c)(8) and (c)(9))
    J. Premarket Approval Application (PMA)/Section 510(k) Number 
and Combination Product Status (Sec.  803.52(e)(5))
    K. New, Changed, or Corrected Information (Sec.  803.56(c))
    L. Paper Responses to Requests for Additional Information
    M. Analysis of Impact
    N. Common Errors
    O. Effective Date
    P. General Comment Concerning Numeric Data Fields
    Q. Receipt Date
    R. Software Changes
    S. System Outages
IV. What is the legal authority for this rule?
V. What is the environmental impact of this rule?
VI. What is the economic impact of this rule?
    A. Benefits
    B. Costs
    C. Summary of Benefits and Costs
    D. Regulatory Alternatives to the Final Rule
    E. Regulatory Flexibility Analysis
VII. How does this rule comply with the Paperwork Reduction Act 
(PRA) of 1995?
    A. Reporting Requirements
    B. Recordkeeping Requirements
    C. Changes From the Proposed Rule
    D. Total Annual Cost Burden
VIII. Does this final rule have federalism implications?
IX. What is the effective date?
X. What references are on display?
XI. Stayed CFR Text

I. History of the Medical Device Reporting Regulation

    The MDR regulation was first published on September 14, 1984 (49 FR 
36326), with requirements for manufacturer and importer reporting of 
deaths, serious injuries, and malfunctions effective December 13, 
1984.\1\ FDA's regulations governing medical device adverse event 
reporting implement section 519 of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 360i). Section 519 of the FD&C Act has 
undergone several changes since its enactment as part of the Medical 
Device Amendments of 1976 (Pub. L. 94-295). As a result, FDA's 
regulations at part 803 (21 CFR part 803) have also undergone multiple 
revisions. The Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-
629) amended the FD&C Act to require mandatory reporting of device 
adverse events by user facilities (deaths reported to FDA and the 
manufacturer, and serious injuries or illnesses reported to the 
manufacturer) and domestic distributors (deaths and serious injuries or 
illnesses reported to FDA and the manufacturer, and certain 
malfunctions reported to the manufacturer). The SMDA also amended the 
FD&C Act to require manufacturers and distributors (including 
importers) to certify the number of MDRs submitted to the Agency each 
year and to require user facilities to submit a semiannual report 
summarizing reportable events. FDA published a tentative final rule on 
November 26, 1991 (56 FR 60024), to implement the SMDA requirements for 
reporting for device manufacturers, user facilities, and distributors, 
including importers (the 1991 tentative final rule). By statute, user 
facility reporting became effective on November 28, 1991, and 
distributor reporting became effective on May 28, 1992.
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    \1\ See 49 FR 36644, September 19, 1984 (correcting the 
effective date).
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    On June 16, 1992, the Medical Device Amendments of 1992 (the 1992 
amendments) (Pub. L. 102-300) further amended certain provisions of 
section 519 of the FD&C Act relating to reporting of adverse device 
events. The amendments adopted a single reporting standard and 
definition for serious injury/serious illness for manufacturers, 
importers, distributors, and user facilities. The changes under the 
1992 amendments were effective on June 16, 1993.
    On September 1, 1993, FDA published a final rule (58 FR 46514) that 
collected the requirements for all wholesale distributors, importers as 
well as domestic, under a new part 804 (21 CFR part 804).
    On December 11, 1995 (60 FR 63578), FDA published a final rule for 
manufacturers and user facilities (the 1995 final rule), with changes 
from the 1991 tentative final rule, including a requirement for the use 
of the Form

[[Page 8833]]

FDA 3500A for reporting. The proposed effective date of April 11, 1996, 
for the 1995 final rule was extended to July 31, 1996 (61 FR 16043, 
April 11, 1996).
    On November 21, 1997, the Food and Drug Administration 
Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) was enacted. FDAMA 
made changes regarding the reporting of adverse experiences related to 
devices, including a stay of the requirement for Annual Certification 
by manufacturers and distributors, elimination of the requirements for 
adverse event reporting by domestic distributors, and a change from 
semiannual reports to annual reports for user facility summary reports. 
On May 12, 1998, FDA published a direct final rule (63 FR 26069) and a 
companion proposed rule (63 FR 26129) to implement these changes to the 
MDR requirements, which included transferring distributor requirements 
back to part 803. FDA received significant adverse comments on the 
direct final rule and companion proposed rule; therefore, FDA withdrew 
the direct final rule and published a revised final rule in the Federal 
Register of January 26, 2000 (65 FR 4112). Under the FD&C Act as 
amended by FDAMA, distributors who were not importers were no longer 
required to report adverse events but were still required to keep 
records. Importers were still required to report adverse events related 
to medical devices. Because of FDAMA's changes, FDA revised part 803 
and removed part 804.
    On February 28, 2005, FDA revised the MDR regulation (70 FR 9516) 
by adopting plain language to make the requirements easier to 
understand (the 2005 plain language MDR direct final rule).
    On June 13, 2008, FDA published a direct final rule (73 FR 33692), 
and a companion proposed rule (73 FR 33749) to remove the requirement 
for baseline reports, which were determined largely to duplicate 
information provided in individual adverse event reports. On September 
17, 2008, FDA published a notice (73 FR 53686) confirming the effective 
date for the direct final rule as October 27, 2008.
    On August 21, 2009, FDA published a proposed rule (74 FR 42203) to 
amend part 803 to require manufacturers, importers, and user facilities 
to submit MDRs to the Agency in an electronic format (the 2009 proposed 
rule). The 2009 proposed rule is now being finalized, subject to 
certain revisions. Because of concerns over the cost of implementation 
for user facilities, and the relatively low volume of reports FDA 
receives from such facilities, the final rule does not require user 
facilities to adopt electronic reporting. FDA believes that the 
benefits of this rule can be achieved without applying the electronic 
reporting requirement to user facilities. Although FDA encourages user 
facilities to file reports electronically, they may continue to use 
paper forms for reporting. The rule revises references to the use of 
paper forms for reporting and makes electronic reporting mandatory for 
manufacturers and importers. Additionally, the rule modifies the 
existing regulation to list information for reprocessed single use 
devices, in order to reflect changes already made to the Form FDA 
3500A, in accordance with MDUFMA (Pub. L. 107-250).

II. Overview of the Final Rule

A. Changes to the 2009 Proposed Rule

    The 2009 proposed rule included only the parts of the regulation 
that contained amended and changed language. The final rule contains 
part 803 in its entirety for ease of reading and clarity.
    The 2009 proposed rule proposed to remove the definition for 
``Five-day report'' from Sec.  803.3 as unnecessary since it merely 
referred to a report under Sec.  803.53. Because there is still a 
requirement for 5-day reports, we have concluded that removing the 
definition could be confusing to reporting entities and have decided to 
retain the definition.
    The 2005 plain language MDR direct final rule removed the 
enumeration of definitions under Sec.  803.3. Subsequent difficulties 
when referencing specific definitions have suggested that we should 
reinstitute numbering the definitions and have done so in this final 
rule.
    Certain terminology used in the proposed rule has changed in the 
final rule. References to CeSub (CDRH eSubmitter) have been revised to 
reflect the current FDA-wide term used for electronic submissions, 
eSubmitter.
    In addition, under this final rule, a manufacturer or importer 
needs to request and obtain an exemption from electronic reporting to 
continue to report via hardcopy past the effective date for electronic 
reporting. The 2009 proposed rule used the term ``variance'' at the end 
of section Sec.  803.19(b), but we have concluded that ``exemption'' 
more accurately describes the reporting change and have therefore used 
the term ``exemption'' in the final rule. FDA's existing guidance for 
requesting exemptions applies to such requests.
    Technical changes to Sec.  803.11 provide the updated sources for 
Form FDA 3500A.
    Technical changes to Sec.  803.12 update the contact information 
for the FDA/Office of Crisis Management when reporting a public health 
emergency and conform language to other sections of the rule.
    A change was made to Sec.  803.18(b)(1)(iii) to add the word MDR to 
clarify the record retention requirement.
    Technical changes to Sec.  803.19 update the contact information 
for the FDA/CDRH/Office of Surveillance and Biometrics when submitting 
an MDR Exemption Request.
    A change was made to Sec.  803.20(c)(2)(ii) to correct an error, 
such that ``30 days calendar'' in paragraph (b)(2)(ii) of the current 
rule was revised as ``30 calendar days'' in what is now paragraph 
(c)(2)(ii).
    Technical changes to Sec.  803.21 provide the current Web site 
addresses for obtaining adverse event reporting codes information. This 
part also provides the current contact information for the FDA/CDRH/
Division of Small Manufacturers, International, and Consumer Assistance 
(DSMICA).
    Technical changes to Sec.  803.33 provide the updated sources for 
Form FDA 3419.

B. Highlights of the Final Rule

    For over 20 years, FDA received postmarket MDRs in a paper format 
through the mail. In 2008, FDA permitted manufacturers to submit 
postmarket MDRs electronically, on a voluntary basis. This final rule 
to require the electronic submission to FDA of manufacturer and 
importer MDRs is an important step toward improving the Agency's 
systems for collecting and analyzing postmarket MDRs. When 
manufacturers and importers submit data elements to FDA in a paper 
format, the information must be manually entered into our internal 
electronic database before it can be effectively reviewed and analyzed. 
Under the proposed rule, this data entry will be performed by the 
manufacturers and importers and they will save the cost of submitting 
the paper forms. More importantly, eliminating that step will make the 
information available more quickly to FDA.
    This final rule includes reports of deaths, serious injuries, and 
malfunctions that must be reported to FDA in initial 5-day, 10-day, or 
30-day individual MDRs as well as information that must be reported to 
FDA in supplemental or followup reports. It does not change the 
underlying reporting requirements, just the manner in which they are 
submitted to FDA. This final rule will have the following benefits:

[[Page 8834]]

     Reducing industry's time and costs associated with 
transcribing data from internal data management systems to paper and 
mailing the paper reports to the Agency;
     Reducing the Agency's transcription errors, time, and 
costs associated with receiving paper reports and transcribing data to 
electronic format for review and analysis;
     Expediting the Agency's access to safety information in a 
format that supports efficient and comprehensive data analysis and 
reviews; and
     Enhancing the Agency's ability to rapidly communicate 
information about suspected problems to the medical device industry, 
health care providers, consumers, and other government Agencies.

C. How do I submit MDRs in electronic format?

    Upon the effective date of this final rule, manufacturers and 
importers are required to submit MDRs to the Agency in an electronic 
format that FDA can process, review, and archive. The most specific and 
updated information about how to create, format, and transmit reports 
electronically using the eSubmitter software (for low volume reporting) 
or the Health Level 7 Individual Case Safety Reports (HL7 ICSR) (for 
high volume reporting), is provided on the Agency's Web site at the 
address identified in the new Sec.  803.23. FDA is committed to 
providing industry with adequate notice of any specifications changes. 
To the extent possible, FDA will ensure previous versions of such 
specifications can still be utilized to submit adverse events 
electronically.
1. What are the options for electronic reporting?
    FDA's CDRH has an MDR database that supports two options for 
electronic submission of MDRs: One allows the submission of a single 
report at a time and one allows submission of batches of reports.
    a. eSubmitter. The Agency developed software (originally referred 
to as CeSub or CDRH eSubmitter) that allows for the submission of one 
MDR at a time. The software allows users to:
     Save address and contact information,
     Search for a Product Code,
     Search for a Patient Problem Code or Device Problem Code,
     Search for Manufacturer Evaluation Codes (method, result, 
and conclusion codes),
     Attach documents when additional information needs to be 
provided, and
     Produce a ``missing data report'' to help ensure that all 
required information is supplied before submission to FDA.
    Once the MDR is completed, the file is ``packaged for submission.'' 
The package generates an electronic version of the Form FDA 3500A, 
which can be submitted to FDA using the FDA Electronic Submission 
Gateway (ESG). The final eSubmitter-generated report can also be saved 
or printed for recordkeeping or to provide reports to manufacturers or 
other entities outside of FDA. The eSubmitter software and instructions 
for installation are free and available at: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm108165.htm. FDA may make minor changes to 
the submission format for maintenance purposes as needed to improve the 
eSubmitter reporting experience.
    b. HL7. Reporters with large numbers of MDRs to report, or those 
that otherwise want to submit reports in batches, may prefer the second 
option, called the HL7 ICSR. The HL7 ICSR was developed in conjunction 
with the HL7 standards organization to support the exchange of 
electronic data. This option allows for the extraction of information 
directly from the reporter's database to populate an MDR, production of 
the appropriate data output, and transmission of the MDR to the FDA 
ESG. In addition, the HL7 ICSR supports the batch submission of more 
than one individual MDR at a time. Reporters developing applications 
using the HL7 ICSR standard may want to consider building functions for 
saving or printing those reports and for attaching documents, such as 
photos or labeling, to their records.
    Additional information is also available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/eMDR-ElectronicMedicalDeviceReporting/default.htm.
2. What is the FDA ESG?
    Both eSubmitter and HL7 reporting options transmit MDRs to FDA 
using the FDA ESG, a secure entry point for all electronic submissions 
to the Agency. To use the FDA ESG, reporters need to have a digital 
certificate. A digital certificate is an attachment to an electronic 
message that allows the recipient to authenticate the identity of the 
sender via third-party verification from an independent certificate 
authority. Digital certificates are used to identify encryption and 
decryption codes between message senders and recipients. Information on 
the FDA ESG and digital certificates is available at: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm113223.htm.
3. How do I know FDA received my electronic submission and it was 
successfully processed?
    FDA's electronic submission processing system sends the submitter 
three different acknowledgments (messages) for each submission. Each 
acknowledgement indicates successful completion of a different 
processing and validation stage for the MDR report and is needed for 
diagnostic purposes. Acknowledgment 1 comes from the FDA ESG and 
indicates your submission was received at the FDA ESG. Acknowledgment 2 
also comes from the FDA ESG and indicates the submission reached CDRH. 
Acknowledgment 3, sent by CDRH through the FDA ESG, notifies you that 
your submission was either successfully loaded into CDRH's adverse 
event database or that your submission contained errors (specified in 
the Acknowledgment) that were identified during validation and loading. 
If there are no errors, we anticipate that the three acknowledgment 
letters will be generated the same day or within 24 hours of the 
submission. If there were errors, you need to correct the errors and 
resend the corrected report in order for your submission to be accepted 
and loaded into the database.
4. How can I obtain an exemption from the requirement to submit a 
report in electronic format?
    Under Sec.  803.19, a manufacturer or importer may submit a written 
request to FDA seeking an exemption from the Sec.  803.12(a) 
requirement to submit reports to the Agency in an electronic format 
that the Agency can process, review, and archive. The written request 
for exemption from electronic format must comply with the requirements 
of Sec.  803.19(b), as well as provide an explanation of why the 
request is justified, including, with appropriate justification, 
financial hardship, and a statement of how long the exemption is 
needed. FDA anticipates receiving few exemption requests relating to 
the electronic reporting requirement because of the availability of the 
Internet, the commercial availability of digital certificates, and free 
access to FDA's eSubmitter Internet software. If FDA grants such an 
exemption, the manufacturer or importer would be allowed to submit 
written MDRs for the period of time specified by FDA in the letter 
authorizing the exemption.

[[Page 8835]]

D. How have the MDR requirements changed?

1. What has changed for user facilities and has annual reporting been 
affected?
    Section 803.30(a) requires user facilities to report information 
required by Sec.  803.32 in accordance with Sec.  803.12(b). User 
facility reports submitted to device manufacturers may also be in paper 
format or an electronic format that includes all required data fields 
to ensure that the manufacturer has all required information. Since 
user facilities will continue to submit annual reports on the paper 
Form FDA 3419, the rule amends Sec.  803.33 to specify where to obtain 
the Form FDA 3419 and where to submit completed annual reports.
2. What has changed for importers?
    The rule amends Sec.  803.40(a) to require submission to FDA of 
information required by Sec.  803.42 in electronic format in accordance 
with Sec.  803.12(a). The mandatory electronic format requirement does 
not apply to importer reports submitted to device manufacturers, which 
may be in paper format or an electronic format that includes all 
required data fields to ensure that the manufacturer has all required 
information.
3. What has changed for manufacturers?
    The rule amends Sec. Sec.  803.50(a), 803.53, and 803.56 to require 
submission of MDR and supplemental report information required by 
Sec. Sec.  803.52, 803.53, and 803.56 in electronic format in 
accordance with Sec.  803.12(a).
4. Are there changes for recordkeeping?
    Section 803.18 contains requirements for establishing and 
maintaining MDR files or records for manufacturers, user facilities, 
and importers. The rule amends Sec.  803.18(b)(1)(ii) to require 
keeping copies of all reports submitted under part 803, whether paper 
or electronic. (Regulated entities may choose to maintain required 
records, including copies of all reports, either in hardcopy or in 
electronic form). We also are adding Sec.  803.18(b)(1)(iii), to 
require the retention of all acknowledgments that FDA sends the 
manufacturer, importer, or user facility in response to electronic MDR 
submissions.
5. What other changes are in this final rule?
    The final rule does the following:
     Amends Sec. Sec.  803.32, 803.42, and 803.52 to reflect 
the addition to the Form FDA 3500A of a question whether the device is 
a single use device that has been reprocessed and reused on a patient 
and, if so, asking for the name and address of the reprocessor (these 
modifications were already made to Form FDA 3500A and its instructions, 
with Office of Management and Budget (OMB) approval under the Paperwork 
Reduction Act (PRA));
     Changes language in Sec. Sec.  803.32(b)(4), 803.42(b)(4), 
and 803.52(b)(4) from ``date of report by the initial reporter'' to 
``[d]ate of this report,'' to make part 803 consistent with the way 
that other FDA Centers interpret Form FDA 3500A, Block B4, and how 
Block B4 appears on Form FDA 3500A; and
     Makes minor updates to Sec. Sec.  803.32(c), 803.42(c), 
and 803.52(c) and (e) to reflect the changes already made to the forms 
and instructions, including references to the Product Code and PMA/
510(k) number.

III. Comments on the Proposed Rule

A. General

    The Agency received 35 comments on the 2009 proposed rule. Some 
comments expressed concern about the costs of the rule for entities 
that submit only a few reports a year. Other comments expressed concern 
over the effective date and how to handle system outages; others 
included questions about the receipt date and FDA acknowledgments. 
Below is a summary of the comments received, grouped by subject matter.

B. Submitting Initial and Supplemental or Followup Reports (Sec.  
803.12(a))

    (Comment 1) Two comments stated that firms that only submit a few 
reports should be able to send reports on paper. One comment stated 
that the part 11 (21 CFR part 11) electronic documents and signature 
requirement is a burden for firms that never have needed to report 
electronically. The commenters objected to the expense of installing 
and validating the eSubmitter software. One suggested that PDF scans of 
documents be allowed.
    (Response) The Agency disagrees with these comments as they apply 
to manufacturers and importers. Electronic reporting will improve the 
Agency's process for collecting and analyzing postmarket medical device 
adverse event information in a timely and efficient manner. If each 
manufacturer and importer that only had a ``few reports'' was exempt 
from the electronic reporting requirement, the cumulative effect would 
leave FDA with potentially thousands of reports to enter manually. 
Thus, the aggregate effect of exempting such manufacturers and 
importers would significantly undermine the benefits of an electronic 
system of adverse event reporting. The burden and expense of adopting 
electronic reporting is minimal. The eSubmitter software has been 
designed and validated by FDA and is being made available to users for 
free. The user is expected to install and operate the software in 
accordance with the instructions provided by FDA. Section VI provides 
additional detail on the costs associated with this rule. For more 
information regarding the FDA's current thinking and enforcement policy 
relating to electronic records requirements under part 11, see the 
Agency guidance document entitled ``Guidance for Industry: Part 11, 
Electronic Records; Electronic Signatures--Scope and Application'' 
available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072322.pdf5667fnl.pdf.
    The Agency has reassessed the proposal as it applies to user 
facilities, which are required to submit only device-related deaths 
directly to FDA. FDA estimates that user facilities comprise 
approximately two-thirds of all entities subject to reporting 
requirements under part 803, but provide only 3 percent of mandatory 
reports. In light of the anticipated cost for all user facilities to 
implement electronic reporting, the relatively small number of reports 
filed and correspondingly small savings to the Agency from mandating 
electronic reporting by user facilities, FDA is not mandating 
electronic reporting for user facilities at this time. Such facilities 
will be allowed to file paper reports, although--as is the case now--
they can voluntarily choose to use electronic reporting, and the Agency 
encourages them to adopt electronic filing.
    (Comment 2) One comment stated that FDA should allow the 
manufacturer to submit a supplemental report before issuing a request 
for additional information.
    (Response) The Agency disagrees with this comment. We issue a 
request for additional information when our analysis of available 
submissions from the manufacturer identifies a need for additional 
information. Processing of paper submissions involves backlogs and 
delays in entry of the information into the database. One advantage of 
electronic reporting is that supplemental reports will be quickly 
available for review. Ready access to supplemental report information 
may reduce the need for additional information requests.

[[Page 8836]]

C. Establishing and Maintaining MDR Records (Sec.  803.18)

    (Comment 3) Two comments considered the required .xml format to be 
a problem. One said that FDA field investigators may not be able to 
accurately interpret the electronic MDR .xml files to determine if the 
MDR is adequate or if the MDR was submitted on time. The second said 
that the .xml format is difficult for people to read and FDA should 
provide guidance on creating acceptable MDR documents from submitted 
.xml files that can be used by FDA field investigators.
    (Response) The Agency does not believe that the .xml format is 
inherently problematic, but the Agency has developed guidance to assist 
entities with eMDR issues and a notice of availability for this 
guidance appears elsewhere in this issue of the Federal Register. 
Reporting entities that develop applications using the HL7 ICSR 
standard are encouraged to develop functions to save or print the 
reports in a human readable format. The reporting entities will need to 
validate that the human readable format is an accurate representation 
of what was submitted.

D. Copies Kept in MDR Files of All Reports Submitted (Sec.  
803.18(b)(1)(ii))

    (Comment 4) One comment stated that the reference to paper is no 
longer necessary and should be deleted from the phrase ``(whether paper 
or electronic)''.
    (Response) The Agency disagrees because paper copies will still be 
used in certain circumstances. A reporting entity that files paper 
copies of MDR reports with FDA or other entities could choose to 
maintain a paper copy of the report in its MDR event files. A reporting 
entity that uses HL7 to file an electronic MDR can maintain either an 
electronic or paper copy of the MDR in its MDR files, but the HL7 
application needs to have validated that any paper copy produced is an 
accurate representation of the electronic copy filed with FDA. A 
reporting entity that uses eSubmitter to file an electronic MDR can use 
a feature of eSubmitter to produce a paper copy of the MDR when it is 
needed and validation of the copy is not required. If a reporting 
entity is granted an exemption from electronic reporting and the MDR 
report is sent on paper, it is likely that the entity would maintain a 
paper copy of the report sent to FDA in the MDR event file.

E. Copies of All Electronic Acknowledgments (Sec.  803.18(b)(1)(iii))

    (Comment 5) One comment stated that FDA is requiring manufacturers 
to keep all three of the acknowledgments sent by FDA even though the 
MDR filing is not considered successful until the firm receives 
Acknowledgment 3 and it shows the submission did not fail. The 
commenter recommended changing the regulation to eliminate retaining 
all of the acknowledgments sent by FDA. The commenter suggested 
requiring manufacturers to retain only proof of the MDR being filed and 
not the acknowledgments sent by FDA, or only the final acknowledgment. 
According to the commenter, Acknowledgments 1 and 2 should be invisible 
to the manufacturers; a single acknowledgment to the manufacturer 
should suffice.
    (Comment 6) One comment stated that the three acknowledgments sent 
by FDA are cumbersome and difficult to link together. The commenter 
suggested consolidating the acknowledgments.
    (Response) The Agency disagrees. Each acknowledgment sent by FDA 
indicates the stage of processing that has been reached (FDA ESG 
received, CDRH received, CDRH loaded into database) and whether it has 
been successfully processed. The date the report reaches the FDA ESG 
(marked by Acknowledgment 1) is considered the date received only if 
the report is successfully loaded into the CDRH database (marked by 
Acknowledgment 3), and Acknowledgment 2 links the information from the 
other two acknowledgments. If the submission has data errors, it will 
not be loaded into the CDRH database, and the submission must be 
corrected and resubmitted. All three acknowledgments are needed to 
trace the reference numbers from the initial receipt at FDA's ESG to 
the successful loading of the submission into the CDRH database, and 
the comments do not indicate why retention of them would be 
particularly burdensome. Until a report has been successfully 
processed, the reporting entity has not satisfied the requirement for 
submission of the MDR report. Moreover, in the event there is a 
question or problem relating to a submission, the receipt or lack of 
receipt of each of the three acknowledgments will assist the reporter 
and CDRH in determining the status of the report and will allow a 
reporter to identify and address any problems. For instance, failure to 
receive Acknowledgment 1 would indicate that it was not successfully 
received by the FDA ESG; if there was only one consolidated 
acknowledgment, the reporter would not know which aspect of the 
transmission failed and would not identify the problem as easily.
    (Comment 7) One comment suggested that the Agency add a question, 
``When can I expect to receive my three acknowledgment notices?'' to 
the eMDR guidance document.
    (Response) FDA has added the question ``How do I know FDA received 
my Electronic Submission and it was successfully processed?'' to the 
preamble (see section II, Overview of the Final Rule). Moreover, FDA 
has addressed this question in the final guidance document for eMDR.
    (Comment 8) One comment asked what to do if the firm does not 
receive all of the acknowledgments.
    (Response) FDA considers a submission to be complete when all three 
acknowledgments have issued, indicating that the report has been 
successfully loaded in the CDRH adverse event database. If you do not 
receive Acknowledgments 1 or 2, and the ESG Web site does not indicate 
that there are problems with the operation of the FDA ESG, you should 
contact the FDA ESG staff. If you do not receive Acknowledgment 3, and 
the electronic MDR (eMDR) status page does not indicate that there are 
problems with the operation of eMDR, you should send an email message 
to: eMDR@fda.hhs.gov. If Acknowledgment 3 states that your report 
failed to load, the letter will identify errors in your submission. You 
will need to correct the errors and resubmit the report, at which time 
you will receive another set of three acknowledgments.
    FDA considers the receipt date for electronic adverse event report 
submissions to be the date the submission arrived at the FDA ESG, but 
only if the submission is successfully loaded in the CDRH database. If 
a report is resubmitted and the resubmission is successfully loaded, 
the receipt date will be the date that the resubmission arrived at the 
FDA ESG.
    Criteria that could cause a submission to fail include, but are not 
limited to, failure to provide data in a required field, failure to use 
the appropriate format for a field (e.g. an incorrect date format), 
data that exceeds the number of characters allowed for a field, or an 
invalid Report Number (e.g. the year and sequence number reversed or a 
sequence number reused). If there is a problem with the ESG or eMDR, 
FDA will post information concerning the problem on the appropriate Web 
site. You would not need to contact FDA, but should keep records of 
your attempt to submit MDR reports. FDA will use the Web site to advise 
when to expect operations to return to normal so that resubmission can 
be made. If you have questions during that time, send an

[[Page 8837]]

email in accordance with the instructions at the eMDR Web site: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm or the ESG Web 
site: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm.

F. Manufacturer Reporting Requirements (Sec.  803.50(a))

    (Comment 9) Two commenters asked for clarification about what date 
and time FDA will accept as timely submission. One comment stated that 
the Agency should clarify when electronic MDRs are considered to be 
reported, upon receipt into the FDA ESG or upon notification by CDRH 
that the report has been successfully loaded into CDRH's adverse event 
database. The second comment asked the Agency to specify what time zone 
to use to determine the 30-day requirement and recommended that the 
time zone of the submitter should be used.
    (Response) For paper reports, FDA considers the postmark date or 
the date shipped by a delivery service to be the date the event was 
reported. For electronic reports, the date the eMDR submission is 
received at the FDA ESG is identified as the receipt date (i.e. the 
date the event was reported) for the MDR report, if the report is 
successfully loaded in the CDRH database. If a report cannot be loaded 
by CDRH, it is rejected and must be corrected and resubmitted. FDA does 
not have the benefit of the report information until the report is 
successfully loaded.
    The time zone should not be a concern for timely reporting under 
MDR. The FDA ESG acknowledgment letter (Acknowledgment 1) displays both 
the date and time according to the Eastern Standard Time (EST)/Eastern 
Daylight Time (EDT) zone; however, MDR considers only the date for the 
purposes of calculating timely reporting. If the report is successfully 
loaded, this processing should take no more than an hour. Although 
Acknowledgment 1 displays EST/EDT, for purposes of timeliness FDA will 
consider the local time of the submitter, just as a postmark date is 
used for mailed paper reports. See section III.Q for further 
information.

G. Report Date (Sec.  803.52(b)(4))

    (Comment 10) One comment stated that to avoid confusion the Agency 
should revise Sec.  803.52(b)(4) back to the language in the current 
MDR regulation, to state: ``Date of the report by the initial 
reporter.'' According to the comment, that date, plus the date required 
under Sec.  803.52(e)(4), ``Date received by you'' would permit a clear 
tracking of compliance with the regulation's reporting timeframes.
    (Response) FDA disagrees. The date received by you is the date that 
you become aware of the event, which is also reported elsewhere on Form 
FDA 3500A. We are asking for the ``Date of this report'' to provide the 
reporting entity with a means of documenting the date that the MDR is 
submitted to FDA. This change will make the information requested for 
device reports consistent with the information recorded by other 
Centers for products that are reported using the Form FDA 3500A.

H. Product Code and Common Device Name (Sec.  803.52(c)(2))

    (Comment 11) One comment stated that there is no need for both the 
product code and the common device name. It was suggested that the 
``and'' be replaced with an ``or.''
    (Response) FDA disagrees. The product code does not always match 
directly with a single common device name. Using both the product code 
and common device name provides FDA more specific information 
concerning the device that is the subject of the adverse event report. 
The product code is information that was initially required for the 
baseline report, and is needed as part of the information for Form FDA 
3500A because the baseline report requirement has been removed from the 
MDR regulation. (See section I).

I. Name and Address of the Reprocessor (Revised Sec.  803.52(c)(8) and 
(c)(9))

    (Comment 12) One comment stated that the Agency should revise or 
clarify that these fields [Block D8 and 9 on Form FDA 3500A] apply only 
to reprocessors. An original equipment manufacturer that receives 
information about a reprocessed device for which the name and address 
of the reprocessor is known will send that information to the 
reprocessor because the reprocessor is the manufacturer for the 
purposes of MDR reporting.
    (Response) FDA disagrees. Form FDA 3500A was modified as a result 
of the MDUFMA mandate. The form and instructions specify that under 
Block D. Suspect Medical Device, field 8 should be answered to identify 
single use devices that are reprocessed, and if the answer to field 8 
is yes, field 9 should be completed to identify the name and address of 
the reprocessor. With this final rule we are revising the regulation to 
reflect the questions that are part of Form FDA 3500A. Because a 
reprocessor of a single use device is considered a manufacturer, the 
name and address of the reprocessor will also appear in Section G of 
the report form. Although this may result in duplication of 
information, changes to the form are beyond the scope of this 
regulation.

J. Premarket Approval Application (PMA)/Section 510(k) Number and 
Combination Product Status (Sec.  803.52(e)(5))

    (Comment 13) One comment suggested deleting Sec.  803.52(e)(5) 
because PMA/510(k) number and combination product status have never 
been part of the MDR reporting provisions. This information was part of 
the old baseline reports, but the burden for submitting this 
information for each MDR is significantly more onerous than submitting 
this information in one baseline report on the device model. Many 
manufacturers would have to add systems to connect the complaint/MDR 
systems with their submissions systems, significantly increasing the 
economic burden of the rule and adversely affecting the ability to 
comply with electronic MDR requirements timeframes.
    (Response) FDA disagrees. The comment did not provide any support 
for considering this to be a significant burden, and FDA believes there 
is good reason for making this change. FDA added these elements to Form 
FDA 3500A in 2005 because the Agency was removing the baseline 
reporting requirement. The change in the regulation codifies the 
previous changes to the form.

K. New, Changed, or Corrected Information (Sec.  803.56(c))

    (Comment 14) Several comments stated that firms should be able to 
send a new complete report when submitting supplemental reports. One 
comment stated that submissions of additional information should be 
submitted on paper if the initial report was not submitted 
electronically.
    (Response) FDA disagrees. The requirement to report only new, 
changed, or corrected information is consistent with the current 
regulation and the requirements and limitations of the CDRH database 
used for MDRs. FDA is developing specifications for the new database, 
however, and may be able to address this suggestion in the future. The 
use of electronic reporting for supplemental reports will provide FDA 
with more timely access to new, changed, or corrected information to 
facilitate the evaluation of adverse events that are reported.

[[Page 8838]]

L. Paper Responses to Requests for Additional Information

    (Comment 15) One comment asked if responses to requests for 
additional information could be submitted on paper.
    (Response) Yes, a response to a written request for additional 
information under Sec.  803.15 can be submitted on paper. However, the 
use of electronic reporting for responses to requests for additional 
information provides FDA with more timely access to the information to 
facilitate the evaluation of adverse events that are reported. An 
additional information response should include the initial Report 
Number, indicate that the type of followup is a ``Response to FDA 
Request,'' and provide the additional information requested as 
Additional Manufacturer Narrative. Any discrete data elements should 
also be reported as additional manufacturer narrative. You can also 
include a copy of the letter request sent by FDA as an attachment to 
the response.

M. Analysis of Impact

    (Comment 16) One comment stated that our estimate of 10 hours for 
the burden to rewrite standard operating procedures (SOPs) and train 
personnel is too low. In its discussion, the commenter stated that it 
would take at least 40 hours to align a manufacturer's complaint 
handling systems to work compatibly with FDA's eSubmitter software.
    (Response) The comment referred to our burden estimate for setting 
up systems for submission, which we estimated would require 8 to 16 
hours. Our estimate was derived based on firms that maintained their 
MDR records in paper form. Companies with electronic complaint handling 
systems that do not intend to use HL7 ICSR could require approximately 
40 hours to set up eSubmitter. We have amended our analysis of the 
economic impact of this rule to reflect the burden on such companies 
(see section VI).

N. Common Errors

    (Comment 17) One comment suggested that the Agency add to the draft 
guidance a section on common errors that prevent a report from getting 
through the gateway or from being loaded successfully into the CDRH 
database.
    (Response) FDA agrees with this suggestion. Examples of common 
errors include: Failure to provide data in a required field, failure to 
use the appropriate format for a field (e.g. an incorrect date format), 
data that exceeds the number of characters allowed for a field, or use 
of an invalid Report Number. FDA has identified additional errors in a 
guidance document on reporting under eMDR requirements http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm175805.htm.

O. Effective Date

    (Comment 18) Three comments stated that 1 year is not enough time 
for firms to comply with the requirement to submit all MDRs 
electronically. One commenter stated that large firms need adequate 
time to design and implement the large volume option. Another said that 
the activities required for manufacturers to be able to submit eMDRs 
are considerable, particularly for companies with large numbers of 
filings. According to the commenter, software code of internal 
complaint tracking systems will need to be significantly redesigned, 
developed, and validated to send eMDRs, provide attachments, and track 
and retain FDA acknowledgments. Ensuring that implementation of the 
electronic reporting system adheres to the firm's data encryption, 
network, electronic message storage (for acknowledgments), and 
application security policies and architecture will require significant 
analysis and may require major reworking of existing network and server 
architecture as well as security and electronic record retention 
policies. Moreover, successful readiness to submit electronically is 
also dependent upon FDA capacity. The firm recommended that FDA make 
the final rule effective 2 years after the publication of the final 
rule in the Federal Register.
    (Response) FDA generally agrees with these comments. We have 
extended the time to 18 months, which should be enough time for the 
reporting entities to implement electronic reporting. A reporting 
entity that intends to use the HL7 software option, but is unable to 
develop and implement an HL7 application within 18 months of the 
publication of the final rule, can use eSubmitter until the entity is 
ready to use the HL7 application. Moreover, in special cases a firm 
could seek a delay in adopting electronic reporting under Sec.  803.19.
    A CDRH memorandum dated May 8, 2008, provided notice that CDRH was 
ready to accept electronic submissions for MDR reports of individual 
adverse events. The memorandum can be found in the part 11 docket 
Docket No. FDA-1992-S-0039-0054 (formerly Docket No. 92S-0251), 
available at http://www.regulations.gov. See also http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/eMDR-ElectronicMedicalDeviceReporting/default.htm. Voluntary use of electronic reporting has been available 
to industry since that time and a number of manufacturers have already 
adopted electronic reporting.

P. General Comment Concerning Numeric Data Fields

    (Comment 19) One comment indicated that the software for completing 
data fields A2 and A4 (patient age and weight) of the Form FDA 3500A 
only accepts numeric entries. Without numeric information for these 
fields, the report cannot be submitted. The commenter suggested 
providing a mechanism to allow ``no information'' entry in fields A2 
and A4.
    (Response) FDA recognizes that some fields that are numeric do not 
allow for a ``no information'' response, but we cannot change this 
feature in eSubmitter. If a reporting entity using eSubmitter does not 
have a numeric value to enter in an optional field such as A2 or A4, 
and leaves the field blank, the report can be accepted by CDRH. The HL7 
ICSR standard provides for several values for indicating ``no 
information'': ASKU (asked but unavailable), NI (no information), and 
NA (not applicable). Reporters developing applications using the HL7 
standard can use these values.

Q. Receipt Date

    (Comment 20) Three comments stated that the date of the first 
acknowledgment confirming that the submission was received by the FDA 
ESG should be considered the date received. The comments asked FDA to 
confirm that this is the date the Agency will use for regulatory 
purposes. One comment added the suggestion that the Agency combine the 
acknowledgments or provide them in .xml format and link the 
acknowledgments.
    (Response) FDA agrees with the suggestion to clarify when the 
report is considered received. FDA considers the receipt date for 
electronic adverse event report submissions to be the date the 
submission arrived at the FDA ESG, if the submission is ultimately 
loaded successfully. If the submission cannot be loaded successfully, 
Acknowledgment 3 sent to the reporting entity will identify the errors. 
The reporter must correct the errors and resubmit the report. If a 
report is resubmitted and the resubmission is successfully loaded, the 
receipt date will be the date that the resubmission

[[Page 8839]]

arrived at the FDA ESG. Although we consider Acknowledgment 1 to be the 
date received for a submission, if a report is subsequently rejected 
due to errors and must be resubmitted, the date of receipt will be the 
date the FDA ESG receives the resubmission (and a new Acknowledgment 1 
is generated). The reporting entity can document its initial effort to 
submit the report with the information from the first submission but if 
the initial submission failed we would not consider the report received 
until it has been successfully loaded into the CDRH adverse event 
database. See section III.F for further information.

R. Software Changes

    (Comment 21) Three comments questioned FDA's policy and provisions 
for software change control and adequate notice of change. One 
suggested that FDA establish a clear policy for managing and 
communicating software changes and scheduled maintenance and noted that 
high volume reporters would need at least 12 months to implement 
software changes. Another asked FDA to clarify how we will communicate 
changes to software, data fields, and code lists.
    (Response) FDA is committed to providing industry with adequate 
notice of any specification changes and, when possible, will ensure 
previous versions of such specifications can still be utilized to 
submit adverse events electronically. We will utilize our Web sites for 
MDR, eMDR, and FDA ESG as well as Federal Register documents to provide 
sufficient advance notification of changes to all stakeholders. We will 
work with stakeholders on implementation of the changes and expect to 
support previous specifications long enough to ensure that HL7 and 
eSubmitter users are able to make the necessary changes. The FDA ESG 
Web site provides notification of scheduled maintenance and a status 
history that documents unscheduled down time for the FDA ESG.

S. System Outages

    (Comment 22) Four comments stated that FDA has not adequately 
addressed what firms should do when there are system outages and noted 
there are no provisions for compliance when electronic systems ``go 
down.'' Several comments said that FDA should accept paper reports when 
there is a system outage. One comment said that the Agency should 
explicitly provide instruction regarding what reporters need to do when 
the FDA ESG is down. In that event, the comment indicated that 
manufacturers should receive a comparable extension of time to file 
their reports.
    FDA has suggested firms should document attempts at timely filing 
in Block H10 of the MDR form if the manufacturer's electronic systems 
are down. One comment indicated that this expectation should be 
explicitly set forth in the regulation. Doing so would put all firms on 
an even playing field and clarify what must be documented to 
demonstrate MDR compliance to FDA investigators.
    (Response) FDA agrees that firms need to be advised how to document 
problems with timely filing. If either the ESG or a firm's electronic 
system experiences an outage affecting timely reporting, the reason for 
the late submission can be documented by the manufacturer, importer, or 
user facility in Block H10. FDA is not adding this to the rule because 
firms are not required to submit this information.
    The FDA ESG Web site provides notification of planned maintenance 
and maintains a status history that documents times that the FDA ESG 
was not operating. Typically, an ESG system outage has not lasted more 
than 24 hours and should not require an extension of time. If a 
reporting entity is unable to submit a report on time due to an ESG 
outage, it should document its attempts at timely filing in Block H10 
for the affected reports and submit reports electronically as soon as 
the ESG is operational.
    A reporting entity using an HL7 reporting option should plan for a 
backup method of reporting for an outage affecting its own system. If a 
reporting entity experiences an outage within its own system that will 
affect timely reporting, it should contact FDA at the eMDR email 
address: eMDR@fda.hhs.gov. The email should provide FDA with 
information on the problem, the number of reports affected, and an 
estimate of how long it will take to resolve. We will respond 
concerning alternatives for submission of the adverse event reports. A 
description of the problem with the electronic submission should be 
documented in Block H10 for the affected reports before they are 
submitted.

IV. What is the legal authority for this rule?

    FDA's legal authority to amend its regulations governing the 
submission of postmarket medical device adverse event reports for 
medical devices derives from 21 U.S.C. 352, 360, 360i, 360j, 371, and 
374.

V. What is the environmental impact of this rule?

    The Agency has determined under 21 CFR 25.30(h) and (i) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VI. What is the economic impact of this rule?

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). OMB has determined that this final rule is a significant 
regulatory action under the Executive Order.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the eSubmitter program for electronic 
submission of reports does not impose significant costs on small 
entities, the Agency certifies that the final rule will not have a 
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $141 million, using the most current (2012) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    The principal benefit of this final rule will be the public health 
benefits associated with more rapid processing and analysis of the 
initial individual MDRs currently submitted by manufacturers and 
importers to FDA on a paper Form FDA 3500A (about

[[Page 8840]]

190,000 in 2011). In addition, requiring electronic submission of MDRs 
is expected to reduce FDA's annual operating costs by $1.9 million and 
generate annual industry savings of about $9.2 million.
    The total one-time cost for modifying SOPs and establishing 
electronic submission capabilities is estimated to range from $38.4 
million to $42.8 million. Estimated annually recurring costs totaled 
$3.0 million and included maintenance of electronic submission 
capabilities, including renewing the electronic certificate, and for 
some entities, the incremental cost to maintain high-speed Internet 
access. The total annualized cost of the rule, using a 7-percent 
discount rate over 10 years, would be from $8.5 million to $9.1 
million; with a 3-percent discount rate, the annualized cost would be 
$7.5 million to $8.0 million.

A. Need for Regulation

    The purpose of this final rule is to require the submission of MDRs 
in an electronic format the Agency can process, review, and archive. It 
will affect all medical device manufacturers and importers.
    The final rule is part of a greater Agency initiative to adopt 
electronic technologies to improve the quality of our operations and to 
use our resources more efficiently. The rule will reduce FDA's current 
costs associated with processing MDRs that are currently received on 
the paper Form FDA 3500A. By receiving MDRs electronically, FDA should 
be able to access the adverse event information more quickly and at a 
lower cost with anticipated reduced data entry errors by eliminating 
the step of having manufacturers prepare and submit paper forms.
    After considering various alternatives, FDA determined that user 
facilities may continue to submit MDRs in paper form because their 
reports account for only about 3 percent of reports annually. A 
regulation is necessary for reports from manufacturers and importers 
because the Agency receives around 190,000 paper reports from such 
entities and it would be costly for the Agency to maintain the capacity 
to continue to convert paper Form FDA 3500A MDRs to electronic MDR 
records until all manufacturers and importers voluntarily adopted the 
electronic submission format, possibly years in the future. Some 
reporters might never adopt electronic reporting of their own volition.

B. Benefits

    The most important benefit of this final rule will be to the public 
health because the rule will enable the Agency to have quicker access 
to the medical device adverse event reports information and thus more 
quickly identify and act on any medical device problems. In 2011, FDA 
received approximately 201,000 initial MDRs from all sources on the 
paper Form FDA 3500A that needed to be processed and manually entered 
into the FDA database. It can take from 3 days to more than 6 months 
before an MDR submitted on a paper copy of the Form FDA 3500A is 
available for analysis in the Manufacturer and User Facility Device 
Experience (MAUDE) database. With a standardized electronic format, the 
majority of medical device reports will be available for analysis 
within a day or two after submission to the FDA ESG. With a significant 
reduction in the time needed for MDRs to be included in the MAUDE 
database, analysis and action, including feedback to manufacturers and 
consumers, can be initiated sooner--with a corresponding benefit to 
public health.
    The public health benefits will be supplemented with operating cost 
reductions within FDA. Assuming the number of MDRs remains fairly 
constant over time, electronic reporting will save the Agency about 
one-half of the cost of our data entry contract, which equals a savings 
of $1.9 million annually.

C. Costs

    There are about 20,100 medical device manufacturers and importers 
identified in FDA's medical device registration database that will be 
covered by the rule.
    The incremental cost to each affected entity will vary by the size, 
type, and corporate structure of the firm, as well as by its existing 
electronic submission capability. The total costs associated with this 
final rule will include one-time setup costs and annual operating 
costs.
1. One-Time Costs
    One-time costs will be the sum of the costs of:
     Rewriting SOPs and training the appropriate personnel,
     Installing and validating either:
    [cir] The installation of the eSubmitter interface software or
    [cir] The programming and configuration of a computer system to 
transmit reports directly to the FDA ESG using the HL7 ICSR, and
     Acquiring the electronic digital certificate required by 
the FDA ESG.
    a. Rewriting SOPs and training personnel. All entities subject to 
the electronic reporting requirement will need to ensure that their 
SOPs include the electronic submission requirement. We estimate that it 
will require about 10 hours to make the modifications and train the 
appropriate people on the new procedures. The estimated one-time 
incremental cost for updating SOPs, assuming an average wage rate of 
$63 per hour,\2\ is about $12.7 million (20,100 medical device 
manufacturers and importers x 10 hours x $63/hour).
---------------------------------------------------------------------------

    \2\ $63 per hour wage is based on U.S. Bureau of Labor 
Statistics (BLS) Occupational Employment and Wages, May 2010, for 
Medical and Health Service Managers, Standard Occupational 
Classification 11-9111. Forty percent was added to the mean hourly 
wage of $45.03 to account for benefits and the total was rounded to 
$63.
---------------------------------------------------------------------------

    b. Setting up systems for submission. MDRs will be submitted 
through the FDA ESG using one of two methods: The eSubmitter software 
or the HL7 ICSR. Because most entities are small and submit few if any 
MDRs annually, we assume they will use the eSubmitter software, which 
allows for the submission of one MDR at a time. To comply using this 
submission method, manufacturers and importers will need high-speed 
Internet connections \3\ and will have to download and install up to 
three free software programs, validate the installation, and train the 
appropriate personnel on the new procedures. Entities that have 
dedicated information technology staff will be able to install and 
validate the installation themselves. Smaller manufacturers and 
importers will probably choose to hire an outside contractor for the 
installation and the validation of the installation.
---------------------------------------------------------------------------

    \3\ While it is possible to submit reports with a slower, dial-
up, connection, we believe most manufacturers and importers that do 
not have high-speed connections already would upgrade their Internet 
access because it is more efficient. The efficiencies of high speed 
Internet access could also benefit other parts of firms' business 
systems.
---------------------------------------------------------------------------

    FDA does not have data on the amount of time required to install 
and validate the installation of the software or the percentage of 
entities that might need to contract out the installation. For this 
analysis, FDA assumes that it will take 8 to 16 hours to install and 
validate the installation of the eSubmitter software (and to install, 
if necessary, Java Runtime Edition software and Java security policy 
files for their Internet browser) for manufacturers and importers who 
maintain paper records. FDA assumes it could take about 40 hours for 
manufacturers and importers who maintain electronic records (and thus 
need extra time to ensure that their systems can communicate with FDA 
ESG). These time totals also include the time required to notify FDA, 
run a test submission through the FDA ESG, and to train the appropriate 
staff to use the new program. FDA also assumes that

[[Page 8841]]

almost all medical device manufacturers and importers will use this 
method to submit MDRs. Using an average wage of $52 for computer and 
mathematical occupations,\4\ we estimate the cost to install and use 
the software to be between $25.2 million and $29.4 million [((8 hours x 
$52 wage x 10,050 manufacturers and importers) + (40 hours x $52 wage x 
10,050 manufacturers and importers)) to ((16 hours x $52 wage x 10,050 
manufacturers and importers) + (40 hours x $52 wage x 10,050 
manufacturers and importers))].
---------------------------------------------------------------------------

    \4\ BLS Occupational Employment and Wages, May 2010 by 
occupation, for all industries (http://www.bls.gov). Wage ($52) 
includes mean hourly wage of $37.13 for Standard Occupational 
Classification 15-0000, computer and mathematics occupations, all 
industries; we add 40 percent to account for benefits and rounded to 
$52 for ease of calculations. (FDA has verified the Web site 
address, but FDA is not responsible for any subsequent changes to 
the Web site after this document publishes in the Federal Register.)
---------------------------------------------------------------------------

    Entities that submit a large number of MDRs each year may choose to 
use the HL7 ICSR method to submit the reports. This method allows for 
the batch submission of multiple MDRs at faster transmission rates. The 
Agency does not know the threshold at which it becomes cost effective 
for an entity to submit medical device reports using this method. An 
analysis of FDA submission data for a 6-year period indicated that 
about 20 medical device manufacturers submit 500 or more MDRs each year 
and about 85 submit close to 100 medical device reports per year. We 
assume that the actual number of entities that would begin using the 
HL7 ICSR as a result of this rule would fall somewhere within this 
range (20 to 105). We also assume that only entities that have existing 
infrastructure to support HL7 ICSR transmissions would choose this 
method to submit MDRs. We estimate that it will take about 50 hours to 
set up their gateway to be compatible with the Agency's system. Using 
the wage $52, the one-time cost for establishing HL7 ICSR submission 
capabilities will range between $52 thousand and $273 thousand [($52 x 
50 hours) x 20 entities) and ($52 x 50 hours) x 105 entities)].
    c. Electronic certificates. All entities will need an electronic 
certificate to submit any electronic regulatory document to the FDA 
ESG. The electronic certificate identifies the sender and serves as an 
electronic signature. Entities that have not submitted any electronic 
documents to the Agency will incur a one-time cost to acquire the 
certificate and recurring costs to keep the certificate active as a 
result of this final rule. The certificates cost about $20 and are 
valid for 1 year. We assume that the search and transactions costs 
involved in the initial acquisition of the certificate doubles the cost 
of the certificate to a total cost of $40 for the first year, half of 
which would be setup costs. If all entities needed to acquire 
electronic certificates, the one-time initial costs of the certificates 
would be $402,000 ($20 initial acquisition cost x 20,100 entities).
    d. Summary of one-time costs. In addition to the costs we have 
estimated, manufacturers and importers affected by this final rule may 
have to hire outside experts to install and validate the software 
installation to comply with these requirements.
    Table 1 summarizes the estimated one-time costs for this rule. The 
estimate of the total one-time costs for all affected entities ranges 
from $38.4 million to $42.8 million. Much of the cost involves 
acquiring the electronic certificate to submit any regulatory document 
to the FDA, including installation and validation of the eSubmitter 
software or establishment of HL7 ICSR capabilities. For this analysis 
we assume all manufacturers and importers will incur these costs when 
in fact some already have electronic certificates and voluntarily 
submit MDRs electronically.

                                                           Table 1--Summary of One-Time Costs
                                                                       [$ million]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Install and validate       Establish HL7 ICSR                               Total
                                                Modifying      eSubmitter software           capability          Acquiring  e- -------------------------
                   Industry                        SOPs    ----------------------------------------------------   Certificate
                                                                Low          High         Low          High           \1\           Low          High
--------------------------------------------------------------------------------------------------------------------------------------------------------
One-time costs...............................         12.7         25.2         29.4         0.05          0.3             0.4         38.4         42.8
Annualized at 3-percent over 10 years........  ...........  ...........  ...........  ...........  ...........  ..............          4.5          5.0
Annualized at 7-percent over 10 years........  ...........  ...........  ...........  ...........  ...........  ..............          5.5          6.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ This refers to the $20 initial cost to acquire the e-certificate; the rest of the cost of the certificate is captured in the calculation of annual
  costs.

2. Annual Costs
    The annual costs of this final rule will include the costs of:
     Maintaining certificates and
     High-speed Internet access.
    a. Maintaining electronic certificates. Manufacturers and importers 
will bear the cost of maintaining the electronic certificate that 
identifies the sender. In addition to having to renew the certificate 
on a regular basis, those entities who have not submitted MDRs will 
also have to ensure that they are capable of transmitting electronic 
MDRs to FDA should such a report submission be necessary. To add these 
costs to the cost of the certificate itself, we assume that entities 
will incur an additional annually recurring cost equal to one-half the 
price of the certificate ($10), for a total annually recurring cost of 
$30. If all manufacturers and importers need to acquire electronic 
certificates, the annual cost would be $0.6 million ($30 acquisition 
certificate renewal and acquisition cost x 20,100 entities).
    b. High-speed Internet access. We have assumed that entities will 
also use high-speed Internet access to use either of the submission 
methods. A 2010 study of small businesses sponsored by the Small 
Business Administration (SBA) found that essentially all small firms 
had Internet access and about 80 percent had high-speed Internet access 
(Columbia Telecommunications Corp., 2010). The average cost of high 
speed access was about $40 per month more than dial-up access. Because 
the average medical device manufacturer is very small and very small 
firms had somewhat lower access than the average, we estimate that by 
the time this final rule is in effect, about 75 percent of 
manufacturers and importers will have high speed access. The average 
annual recurring increase in cost for high speed Internet access for 
the remaining 25 percent of the entities would be approximately $2.4 
million

[[Page 8842]]

(($40 x 12 months) x 0.25 x 20,100 manufacturers and importers).
    c. Summary of annual costs. The annual costs of the rule are $3 
million ($0.6 million for electronic certificates + $2.4 million for 
internet access). As with the one-time costs, only entities not already 
making electronic regulatory document submissions of any kind to the 
Agency when this rule is published will incur these costs. There will 
be no change in the actual time required to research and prepare the 
MDRs, nor will there be any additional reporting requirements as a 
result of this final rule. Manufacturers and importers that maintain 
Form FDA 3500A records in paper format for their internal MDR files can 
still do so under this final rule.
    d. Cost savings. FDA estimates an industry savings of about $9.2 
million annually because electronic submission should reduce the time 
it takes to submit documents and reduce postage or delivery 
expenditures. The time savings estimate was derived using the estimated 
savings (i.e., from reduced burdens) reported in section VII. Device 
manufacturers and importers are expected to save a weighted average of 
0.89 hours per submission. Savings from reduced postage costs will be 
around $0.4 million. FDA assumed that without this rule the Agency 
would continue to receive about 190,000 submissions in paper format.\5\ 
FDA calculated the total savings as 190,000 submissions x 0.89 hour 
savings x $52 wage cost per hour + .8 x [(1,630 firms x 12 months x ($5 
flat rate priority mail + $20 flat rate express mail))].\6\
---------------------------------------------------------------------------

    \5\ The estimated 190,000 submissions from 1,630 firms are based 
on the number of submissions for 2011.
    \6\ This estimate differs from the paperwork estimates in 
section VII because it measures the incremental change from current 
practice rather than the time to comply with specific requirements. 
Postage was calculated using flat rate charges by the U.S. Postal 
Service and assuming that 80 percent of the firms submitting paper 
MDRs in a given year would submit one express package and one 
priority mail package per month.
---------------------------------------------------------------------------

D. Regulatory Alternatives to the Final Rule

    The Agency identified and assessed two additional regulatory 
alternatives to this final rule. The first of these alternatives would 
allow manufacturers and importers to voluntarily submit MDRs 
electronically. This regulatory alternative would allow firms to choose 
paper or electronic submissions, but would require any electronic 
submissions to use either the eSubmitter or the HL7 ICSR. This 
alternative would reduce the one-time set costs (see table 1) for firms 
choosing not to make electronic submissions; those firms would also 
fail to realize corresponding savings. For many firms, the expected 
private costs of adopting electronic submissions will exceed expected 
private benefits due to having higher discount rates, higher costs than 
the averages presented here, or shorter planning horizons than the 10 
years used in this analysis; FDA therefore expects that under this 
alternative a number of medical device firms would resist changing 
their procedures for a long period of time, perhaps indefinitely. If a 
substantial number failed to voluntarily adopt electronic submission of 
MDRs, FDA would not obtain the benefits of standardized formats and 
quicker access to medical device adverse event data. The Agency would 
also have to maintain significant capacity for accepting and processing 
written MDRs. A voluntary system, therefore, would fail to achieve the 
public health benefits and efficiency goals of the final rule.
    The second regulatory alternative would allow small entities more 
time to comply with the electronic submission requirements. This 
alternative would allow small entities to delay compliance. Under this 
alternative, FDA would not achieve meaningful data entry savings from 
requiring electronic submissions or all the benefits of quicker access 
to these reports until the small entity compliance date. Because so 
many device companies are small entities, and in many cases their 
private costs will exceed their private benefits, small entities would 
likely postpone compliance, which would significantly postpone the 
benefits the rule is intended to confer. As shown in the following 
section, the estimated incremental costs per small entity from the 
final rule are small, so the cost reduction per small entity from 
delayed compliance would also be small. Moreover, postponing compliance 
would not reduce the future setup costs once the later compliance date 
is reached. In other words, postponing compliance would simply postpone 
the costs and benefits with no change in their amounts.

E. Regulatory Flexibility Analysis

    SBA defines a small medical device manufacturer as having fewer 
than 500 employees (NAICS 325413, 334510, 334517, 339112, 339113, 
339114, and 339115). Over 90 percent of registered device firms 
affected by this final rule are considered small entities under this 
definition. While this final rule will now require many MDR reports 
submitted to the Agency to be in electronic format, the content of a 
report is not being changed from that already addressed on the paper 
Form FDA 3500A. The average costs for these manufacturers and importers 
are listed in table 2. The average total annualized cost per small 
entity, assuming a 7-percent discount rate over 10 years, would range 
from $590 to $720 ($575 to $680 at a 3-percent discount rate).
    Because the costs per affected entity are low compared to revenues, 
FDA finds that although this final rule will affect a substantial 
number of small entities, it will not have a significant economic 
impact on those entities. For example, for a facility in NAICS 339114, 
dental equipment and supplies, which have the lowest value of shipments 
of all affected industries, $4.4 million, $721 in annualized costs 
represents about 0.02 percent of revenues. We therefore certify that 
the final rule will not have a significant economic impact on a 
substantial number of small entities.

                             Table 2--Incremental Compliance Costs per Small Entity
----------------------------------------------------------------------------------------------------------------
                                          One-time costs                                 Total annualized
                                 --------------------------------    Annually    -------------------------------
                                        Low            High          recurring          Low            High
----------------------------------------------------------------------------------------------------------------
Rewriting SOPs..................             123             613  ..............  ..............  ..............
Software Installation and                    411             822  ..............  ..............  ..............
 Validation of Installation.....
                                 --------------------------------
Acquiring Electronic Certificate                40                ..............  ..............  ..............
                                 --------------------------------
Maintaining Submission            ..............  ..............              30  ..............  ..............
 Capabilities...................
Upgrade Internet Access.........  ..............  ..............             480  ..............  ..............

[[Page 8843]]

 
7-Percent Discount Rate.........  ..............  ..............  ..............             590             720
3-Percent Discount Rate.........  ..............  ..............  ..............             575             680
----------------------------------------------------------------------------------------------------------------

VII. How does this rule comply with the PRA?

    This final rule contains information collection provisions that are 
subject to review by OMB under the PRA (44 U.S.C. 3501-3520). The 
title, description, and respondent description of the information 
collection provisions are shown in the following paragraphs with an 
estimate of the annual reporting and recordkeeping burden. Included in 
the estimate is the time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing each collection of information.
    Title: Medical Device Reporting: Electronic Submission 
Requirements.
    Description: In accordance with this final rule, medical device 
manufacturers, importers, and user facilities will be required to 
submit electronic MDRs to FDA and to maintain records, and may also 
seek exemption from these requirements. FDA is also amending Sec. Sec.  
803.32, 803.42, and 803.52 by making minor revisions to reflect prior 
modifications to Form FDA 3500A and its instructions. Manufacturers, 
importers, and user facilities are currently submitting paper MDRs on 
Form FDA 3500A, approved under OMB control number 0910-0291. User 
facilities are currently submitting paper annual reports on Form FDA 
3419, approved under OMB control number 0910-0437.
    Section 519(a)(1) of the FD&C Act requires every manufacturer or 
importer to report ``. . . whenever the manufacturer or importer 
receives or otherwise becomes aware of information that reasonably 
suggests that one of its marketed devices may have caused or 
contributed to a death or serious injury, or has malfunctioned and that 
such device or a similar device marketed by the manufacturer or 
importer would be likely to cause or contribute to a death or serious 
injury if the malfunction were to recur. . . .''
    Section 519(b)(1)(A) of the FD&C Act requires that ``[w]henever a 
device user facility receives or otherwise becomes aware of information 
that reasonably suggests that a device has or may have caused or 
contributed to the death of a patient of the facility, the facility . . 
. shall, as soon as practicable but not later than 10 working days 
after becoming aware of the information, report the information to the 
Secretary and, if the identity of the manufacturer is known, to the 
manufacturer of the device.''
    Section 519(b)(1)(B) of the FD& C Act requires that ``[w]henever a 
device user facility receives or otherwise becomes aware of: (i) 
Information that reasonably suggests that a device has or may have 
caused or contributed to the serious illness of, or serious injury to, 
a patient of the facility . . . , shall, as soon as practicable but not 
later than 10 working days after becoming aware of the information, 
report the information to the manufacturer of the device or to the 
Secretary if the identity of the manufacturer is not known.''
    Complete, accurate, and timely adverse event information is 
necessary for the identification of emerging device problems so the 
Agency can protect the public health under section 519 of the FD&C Act. 
FDA is requesting approval for the information collection requirements 
contained in part 803 as revised by this final rule.
    Description of Respondents: Manufacturers and importers of medical 
devices and device user facilities. Device user facility means a 
hospital, ambulatory surgical facility, nursing home, outpatient 
diagnostic facility, or outpatient treatment facility as defined in 
Sec.  803.3, which is not a physician's office (also defined in Sec.  
803.3).
    FDA received 35 comments on the 2009 proposed rule (74 FR 42203). 
Thirteen comments were related to the collections of information. All 
comments are discussed in detail in section III (see comments 1 through 
6, 9 through 14, and 16.)
    To calculate the annual reporting burden for table 3, the number of 
reporting entities that had filed MDRs during 3 years (January 1, 2006, 
through December 31, 2008) was identified along with the number of MDR 
reports filed during that time period. The rate of increase in reports 
and supplements filed was determined and projected for the next 3 
years. The projected total annual responses were calculated by 
multiplying the projected number of respondents by the annual frequency 
per response for the reports and supplements, resulting in the 
estimated total that would be filed by each entity.\7\ The figures 
displayed in table 3 of the 2009 proposed rule were based on MDRs 
processed during the year July 1, 2005, to June 30, 2006, but for this 
final rule FDA has used data for the years 2006 to 2008. One exception 
is the counts under exemption reporting (Sec.  803.19), which reflect 
the number of firms that currently have an exemption and have submitted 
quarterly reports in 2009. The annual burden for reporting calculated 
in table 3 is 37,709 hours.
---------------------------------------------------------------------------

    \7\ In 2012, the actual number of MDR reports submitted was 
712,000, higher than had been estimated.
---------------------------------------------------------------------------

    To calculate the cost figures in table 3, we based our estimates on 
a count of all manufacturers, importers, and user facilities that filed 
MDRs during the period 2006 to 2008. The estimate of capital costs 
included:
     Development of procedures for handling adverse events and 
reporting MDRs,
     Installation of eSubmitter and/or installation and 
validation of H7, and
     Acquiring an electronic certificate.
    The maximum and minimum estimates for installation of eSubmitter 
and HL7 were averaged in the calculations for capital costs. The 
estimate of annual operating and maintenance costs included:
     Renewal of electronic certificate and
     Maintenance of high-speed Internet access.
    The total annual estimated burden imposed by this collection of 
information from tables 3 and 4 is 46,445 hours annually. The approved 
MDR reporting and recordkeeping burden for paper submissions is 391,526 
hours, as approved under OMB control number 0910-0437 (expires August 
31, 2015). Based on 46,445 hours as the reporting and recordkeeping 
burden for electronic submissions, there is a burden decrease of 
345,081 hours. An

[[Page 8844]]

explanation for the burden decrease is provided in the following 
paragraphs:
    FDA estimates the burden of the collection of information as 
follows:

                                                       Table 3--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                Total
                                                                                                                                                annual
                                                                          Number of      Total                                     Total      operating
                21 CFR Section                   Form FDA    Number of    responses      annual    Average burden  Total hours    capital        and
                                                   No.      respondents      per       responses    per response                costs (mil)  maintenance
                                                                          respondent                                                             costs
                                                                                                                                                (mil)
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.19.......................................  ...........           56            4          224            1             224  ...........  ...........
803.30 and 803.32............................  ...........          520            7        3,640            0.35        1,274         $5.9         $0.9
803.33.......................................         3419          520            1          520            1             520  ...........  ...........
803.40 and 803.42............................  ...........           60           25        1,500            0.35          525          1.5          0.1
803.50 and 803.52............................  ...........        1,240          204      252,960            0.10       25,296          6.6          0.5
803.56.......................................  ...........        1,050           94       98,700            0.10        9,870  ...........  ...........
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ...........  ...........  ...........  ...........  ..............       37,709         14.0          1.5
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                     Table 4--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Number of                        Average burden
                        21 CFR Section                              Number of        records per      Total annual           per           Total hours
                                                                  recordkeepers     recordkeeper         records        recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.17........................................................             1,820                 1             1,820               3.3             6,006
803.18(a) through (d).........................................             1,820                 1             1,820               1.5             2,730
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................             8,736
--------------------------------------------------------------------------------------------------------------------------------------------------------

A. Reporting Requirements

    The number of respondents for each applicable Code of Federal 
Regulations (CFR) reporting requirement in table 3 was identified from 
the MDRs reported to FDA's internal databases during the period January 
1, 2006, through December 31, 2008. The annual frequency per response 
and total annual responses shown were based on the number of MDRs 
reported during the same period (January 1, 2006, through December 31, 
2008) with a calculated increase for the next 3 years. FDA estimates 
that electronic submission will decrease the burden associated with 
Sec. Sec.  803.19, 803.30, 803.32, 803.40, 803.42, 803.50, 803.52, and 
803.56.

B. Recordkeeping Requirements

    The number of respondents for each CFR section in table 4 was 
identified from the MDRs reported to FDA's internal databases during 
the period January 1, 2006, through December 31, 2008. The Agency 
believes that the majority of manufacturers, user facilities, and 
importers has already established written procedures and MDR files to 
document complaints and information to meet the MDR requirements as 
part of their internal quality control system, but will need to modify 
their practices to address the electronic reporting process.

C. Changes From the Proposed Rule

    The total burden hours for the proposed rule were 15,200 and total 
burden hours for the final rule are 37,709. This is an increase of 
22,509. The proposed rule calculations were based on MDRs processed 
during the year July 1, 2005, to June 30, 2006. The final rule 
calculations were based on MDR data for the period January 1, 2006, 
through December 31, 2008. The hours per response were adjusted to 
simplify calculations. These changes resulted in an increase in burden 
between the proposed rule and the final rule. The following table 5 
identifies the burden changes from the proposed rule to the final rule.

                                                         Table 5--Changes From the Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Number of respondents    Number of responses per     Average burden per        Total burden hours
                                                 --------------------------        respondent                 response         -------------------------
                 21 CFR Section                                            ----------------------------------------------------
                                                    Proposed      Final       Proposed      Final       Proposed      Final       Proposed      Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.19..........................................           55           56            4            4            1            1          220          224
803.30 and 803.32...............................          411          520            2            7         0.33         0.35          271        1,274
803.33..........................................          411          520            1            1            1            1          411          520
803.40 and 803.42...............................           44           60           20           25         0.33         0.35          290          525
803.50 and 803.52...............................        1,304        1,240           58          204         .011         0.10        8,248       25,296
803.56..........................................        1,200        1,050           48           94         0.10         0.10        5,760        9,870
                                                 -------------------------------------------------------------------------------------------------------
    Total.......................................  ...........  ...........  ...........  ...........  ...........  ...........       15,272       37,709
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The following table 6 summarizes FDA's burden estimates and how 
they will change due to electronic submission. Table 7 summarizes our 
recordkeeping burden estimates and how we believe they will change due 
to electronic submission.

[[Page 8845]]



                               Table 6--Estimated Reporting Burden Program Change
----------------------------------------------------------------------------------------------------------------
                                          Average burden per
                                        response under current     Average burden per    Burden change reduction
            21 CFR Section                 paper submission     response as a result of          (hours)
                                               process           electronic submission
----------------------------------------------------------------------------------------------------------------
803.19...............................                        3                        1                        2
803.30 and 803.32....................                        1                     0.35                     0.65
803.33...............................                        1                        1                      (*)
803.40 and 803.42....................                        1                     0.35                     0.65
803.50 and 803.52....................                        1                     0.10                      0.9
803.56...............................                        1                     0.10                       .9
----------------------------------------------------------------------------------------------------------------
* No change.

    As previously described, there are two reporting options. The first 
one is eSubmitter for low volume reporters, and the second one is HL7 
ICSR for high volume reporters. FDA is basing its hours per response 
estimates on industry's voluntary use of the two systems since May 
2008.

                             Table 7--Estimated Recordkeeping Burden Program Change
----------------------------------------------------------------------------------------------------------------
                                          Average burden per       Average burden per
                                         recordkeeping under       recordkeeping as a    Burden change reduction
            21 CFR Section                  current paper         result of electronic           (hours)
                                          submission process           submission
----------------------------------------------------------------------------------------------------------------
803.17...............................                     10.0                      3.3                      6.7
803.18(a) through (d)................                      1.5                      1.5                      (*)
----------------------------------------------------------------------------------------------------------------
* No change.

D. Total Annual Cost Burden

    The conversion from paper to electronic submissions will result in 
a burden to reporting entities due to both capital costs (one-time 
setup costs) and annual operating and maintenance costs, as 
demonstrated in table 3 and discussed in section VI. The one-time 
capital costs include the cost to develop procedures for handling 
adverse events and reporting MDRs, installing the eSubmitter software 
and/or installing gateway to gateway submission capabilities (HL7), and 
acquiring electronic certificates; these costs have been estimated at 
$14.0 million. Once the procedures have been modified, there is an 
operating and maintenance cost to renew the digital certificate and 
maintain high-speed internet access, which has been estimated at $1.5 
million each year.
    This final rule refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by OMB under the PRA. The revised Form FDA 3500A 
is approved under the PRA, under OMB control number 0910-0291. The 
collections of information in part 803 have been approved under OMB 
control number 0910-0437.
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

VIII. Does this final rule have federalism implications?

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the Agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

IX. What is the effective date?

    This final rule is effective August 14, 2015 (see DATES section). 
Reporting entities that are unable to comply with this date should 
request an exemption following the process described elsewhere in this 
document and in the MDR regulation under Sec.  803.19.

X. What references are on display?

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified the Web site addresses, but is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)

1. U.S. Census Bureau, 2007 Economic Census Industry Series: NAICS 
Code 62, Health Care and Social Assistance, (http://www.census.gov), 
April 1, 2011.
2. BLS Occupational Employment and Wages, May 2010 for Medical and 
Health Service Managers, Standard Occupational Classification, 11-
19111, (http://www.bls.gov), April 1, 2011.
3. Columbia Telecommunications Corp., The Impact of Broadband Speed 
and Price on Small Business, SBA Office of Advocacy Contract Number 
SBAHQ-09-C-0050, (http://archive.sba.gov/advo/research/rs373tot.pdf), November 2010.

XI. Stayed CFR Text

    FDA has many revisions for 21 CFR part 803; therefore, we are 
revising the entire part. At 73 FR 33692, published June 13, 2008, FDA 
amended the MDR regulation to remove Sec.  803.55, which

[[Page 8846]]

established the requirement for baseline reports. Section 803.58, which 
is currently under indefinite stay (published at 61 FR 38346, July 23, 
1996), includes in subsection (b)(1) a reference to the former Sec.  
803.55. For purposes of this rulemaking, FDA is temporarily lifting the 
stay of Sec.  803.58 in order to remove the reference to Sec.  803.55. 
Because FDA is only lifting the stay for this purpose, we are also 
reimposing the indefinite stay of Sec.  803.58 in this final rule. FDA 
intends to consider the Sec.  803.58 requirements for U.S.-designated 
agents in a separate rulemaking.

List of Subjects in 21 CFR Part 803

    Imports, Medical devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
803 is amended as follows:


Sec.  803.58  [Amended]

0
1. The stay of Sec.  803.58 published at 61 FR 38346, July 23, 1996, is 
lifted.
0
2. Revise part 803 to read as follows:

PART 803--MEDICAL DEVICE REPORTING

Subpart A--General Provisions
Sec.
803.1 What does this part cover?
803.3 How does FDA define the terms used in this part?
803.9 What information from the reports do we disclose to the 
public?
803.10 Generally, what are the reporting requirements that apply to 
me?
803.11 What form should I use to submit reports of individual 
adverse events and where do I obtain these forms?
803.12 How do I submit initial and supplemental or followup reports?
803.13 Do I need to submit reports in English?
803.15 How will I know if you require more information about my 
medical device report?
803.16 When I submit a report, does the information in my report 
constitute an admission that the device caused or contributed to the 
reportable event?
803.17 What are the requirements for developing, maintaining, and 
implementing written MDR procedures that apply to me?
803.18 What are the requirements for establishing and maintaining 
MDR files or records that apply to me?
803.19 Are there exemptions, variances, or alternative forms of 
adverse event reporting requirements?
Subpart B--Generally Applicable Requirements for Individual Adverse 
Event Reports
803.20 How do I complete and submit an individual adverse event 
report?
803.21 Where can I find the reporting codes for adverse events that 
I use with medical device reports?
803.22 What are the circumstances in which I am not required to file 
a report?
803.23 Where can I find information on how to prepare and submit an 
MDR in electronic format?
Subpart C--User Facility Reporting Requirements
803.30 If I am a user facility, what reporting requirements apply to 
me?
803.32 If I am a user facility, what information must I submit in my 
individual adverse event reports?
803.33 If I am a user facility, what must I include when I submit an 
annual report?
Subpart D--Importer Reporting Requirements
803.40 If I am an importer, what reporting requirements apply to me?
803.42 If I am an importer, what information must I submit in my 
individual adverse event reports?
Subpart E--Manufacturer Reporting Requirements
803.50 If I am a manufacturer, what reporting requirements apply to 
me?
803.52 If I am a manufacturer, what information must I submit in my 
individual adverse event reports?
803.53 If I am a manufacturer, in which circumstances must I submit 
a 5-day report?
803.56 If I am a manufacturer, in what circumstances must I submit a 
supplemental or followup report and what are the requirements for 
such reports?
803.58 Foreign manufacturers.

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

Subpart A--General Provisions


Sec.  803.1  What does this part cover?

    (a) This part establishes the requirements for medical device 
reporting for device user facilities, manufacturers, importers, and 
distributors. If you are a device user facility, you must report deaths 
and serious injuries that a device has or may have caused or 
contributed to, establish and maintain adverse event files, and submit 
summary annual reports. If you are a manufacturer or importer, you must 
report deaths and serious injuries that your device has or may have 
caused or contributed to, you must report certain device malfunctions, 
and you must establish and maintain adverse event files. If you are a 
manufacturer, you must also submit specified followup. These reports 
help us to protect the public health by helping to ensure that devices 
are not adulterated or misbranded and are safe and effective for their 
intended use. If you are a medical device distributor, you must 
maintain records (files) of incidents, but you are not required to 
report these incidents.
    (b) This part supplements and does not supersede other provisions 
of this chapter, including the provisions of part 820 of this chapter.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.


Sec.  803.3  How does FDA define the terms used in this part?

    Some of the terms we use in this part are specific to medical 
device reporting and reflect the language used in the statute (law). 
Other terms are more general and reflect our interpretation of the law. 
This section defines the following terms as used in this part:
    (a) Ambulatory surgical facility (ASF) means a distinct entity that 
operates for the primary purpose of furnishing same day outpatient 
surgical services to patients. An ASF may be either an independent 
entity (i.e., not a part of a provider of services or any other 
facility) or operated by another medical entity (e.g., under the common 
ownership, licensure, or control of an entity). An ASF is subject to 
this regulation regardless of whether it is licensed by a Federal, 
State, municipal, or local government or regardless of whether it is 
accredited by a recognized accreditation organization. If an adverse 
event meets the criteria for reporting, the ASF must report that event 
regardless of the nature or location of the medical service provided by 
the ASF.
    (b) Become aware means that an employee of the entity required to 
report has acquired information that reasonably suggests a reportable 
adverse event has occurred.
    (1) If you are a device user facility, you are considered to have 
``become aware'' when medical personnel, as defined in this section, 
who are employed by or otherwise formally affiliated with your 
facility, obtain information about a reportable event.
    (2) If you are a manufacturer, you are considered to have become 
aware of an event when any of your employees becomes aware of a 
reportable event that is required to be reported within 30 calendar 
days or that is required to be reported within 5 work days because we 
had requested reports in accordance with Sec.  803.53(b). You are also 
considered to have become aware of an event when any of your employees 
with management or supervisory responsibilities over persons with 
regulatory, scientific, or technical responsibilities, or whose duties 
relate

[[Page 8847]]

to the collection and reporting of adverse events, becomes aware, from 
any information, including any trend analysis, that a reportable MDR 
event or events necessitates remedial action to prevent an unreasonable 
risk of substantial harm to the public health.
    (3) If you are an importer, you are considered to have become aware 
of an event when any of your employees becomes aware of a reportable 
event that is required to be reported by you within 30 days.
    (c) Caused or contributed means that a death or serious injury was 
or may have been attributed to a medical device, or that a medical 
device was or may have been a factor in a death or serious injury, 
including events occurring as a result of:
    (1) Failure,
    (2) Malfunction,
    (3) Improper or inadequate design,
    (4) Manufacture,
    (5) Labeling, or
    (6) User error.
    (d) Device user facility means a hospital, ambulatory surgical 
facility, nursing home, outpatient diagnostic facility, or outpatient 
treatment facility as defined in this section, which is not a 
physician's office, as defined in this section. School nurse offices 
and employee health units are not device user facilities.
    (e) Distributor means any person (other than the manufacturer or 
importer) who furthers the marketing of a device from the original 
place of manufacture to the person who makes final delivery or sale to 
the ultimate user, but who does not repackage or otherwise change the 
container, wrapper, or labeling of the device or device package. If you 
repackage or otherwise change the container, wrapper, or labeling, you 
are considered a manufacturer as defined in this section.
    (f) Expected life of a device means the time that a device is 
expected to remain functional after it is placed into use. Certain 
implanted devices have specified ``end of life'' (EOL) dates. Other 
devices are not labeled as to their respective EOL, but are expected to 
remain operational through activities such as maintenance, repairs, or 
upgrades, for an estimated period of time.
    (g) FDA, we, us, or Agency means the Food and Drug Administration.
    (h) Five-day report means a medical device report that must be 
submitted by a manufacturer to us under Sec.  803.53 within 5 work 
days.
    (i) Hospital means a distinct entity that operates for the primary 
purpose of providing diagnostic, therapeutic (such as medical, 
occupational, speech, physical), surgical, and other patient services 
for specific and general medical conditions. Hospitals include general, 
chronic disease, rehabilitative, psychiatric, and other special-purpose 
facilities. A hospital may be either independent (e.g., not a part of a 
provider of services or any other facility) or may be operated by 
another medical entity (e.g., under the common ownership, licensure, or 
control of another entity). A hospital is covered by this regulation 
regardless of whether it is licensed by a Federal, State, municipal or 
local government or whether it is accredited by a recognized 
accreditation organization. If an adverse event meets the criteria for 
reporting, the hospital must report that event regardless of the nature 
or location of the medical service provided by the hospital.
    (j) Importer means any person who imports a device into the United 
States and who furthers the marketing of a device from the original 
place of manufacture to the person who makes final delivery or sale to 
the ultimate user, but who does not repackage or otherwise change the 
container, wrapper, or labeling of the device or device package. If you 
repackage or otherwise change the container, wrapper, or labeling, you 
are considered a manufacturer as defined in this section.
    (k) Malfunction means the failure of a device to meet its 
performance specifications or otherwise perform as intended. 
Performance specifications include all claims made in the labeling for 
the device. The intended performance of a device refers to the intended 
use for which the device is labeled or marketed, as defined in Sec.  
801.4 of this chapter.
    (l) Manufacturer means any person who manufactures, prepares, 
propagates, compounds, assembles, or processes a device by chemical, 
physical, biological, or other procedure. The term includes any person 
who either:
    (1) Repackages or otherwise changes the container, wrapper, or 
labeling of a device in furtherance of the distribution of the device 
from the original place of manufacture;
    (2) Initiates specifications for devices that are manufactured by a 
second party for subsequent distribution by the person initiating the 
specifications;
    (3) Manufactures components or accessories that are devices that 
are ready to be used and are intended to be commercially distributed 
and intended to be used as is, or are processed by a licensed 
practitioner or other qualified person to meet the needs of a 
particular patient; or
    (4) Is the U.S. agent of a foreign manufacturer.
    (m) Manufacturer or importer report number. This number uniquely 
identifies each individual adverse event report submitted by a 
manufacturer or importer. This number consists of the following three 
parts:
    (1) The FDA registration number for the manufacturing site of the 
reported device, or the registration number for the importer. If the 
manufacturing site or the importer does not have an establishment 
registration number, we will assign a temporary MDR reporting number 
until the site is registered in accordance with part 807 of this 
chapter. We will inform the manufacturer or importer of the temporary 
MDR reporting number;
    (2) The four-digit calendar year in which the report is submitted; 
and
    (3) The five-digit sequence number of the reports submitted during 
the year, starting with 00001. (For example, the complete number will 
appear as follows: 1234567-2011-00001.)
    (n) MDR means medical device report.
    (o) MDR reportable event (or reportable event) means:
    (1) An event that user facilities become aware of that reasonably 
suggests that a device has or may have caused or contributed to a death 
or serious injury or
    (2) An event that manufacturers or importers become aware of that 
reasonably suggests that one of their marketed devices:
    (i) May have caused or contributed to a death or serious injury, or
    (ii) Has malfunctioned and that the device or a similar device 
marketed by the manufacturer or importer would be likely to cause or 
contribute to a death or serious injury if the malfunction were to 
recur.
    (p) Medical personnel means an individual who:
    (1) Is licensed, registered, or certified by a State, territory, or 
other governing body, to administer health care;
    (2) Has received a diploma or a degree in a professional or 
scientific discipline;
    (3) Is an employee responsible for receiving medical complaints or 
adverse event reports; or
    (4) Is a supervisor of these persons.
    (q) Nursing home means:
    (1) An independent entity (i.e., not a part of a provider of 
services or any other facility) or one operated by another medical 
entity (e.g., under the common ownership, licensure, or control of an 
entity) that operates for the primary purpose of providing:

[[Page 8848]]

    (i) Skilled nursing care and related services for persons who 
require medical or nursing care;
    (ii) Hospice care to the terminally ill; or
    (iii) Services for the rehabilitation of the injured, disabled, or 
sick.
    (2) A nursing home is subject to this regulation regardless of 
whether it is licensed by a Federal, State, municipal, or local 
government or whether it is accredited by a recognized accreditation 
organization. If an adverse event meets the criteria for reporting, the 
nursing home must report that event regardless of the nature or 
location of the medical service provided by the nursing home.
    (r) Outpatient diagnostic facility means:
    (1) A distinct entity that:
    (i) Operates for the primary purpose of conducting medical 
diagnostic tests on patients,
    (ii) Does not assume ongoing responsibility for patient care, and
    (iii) Provides its services for use by other medical personnel.
    (2) Outpatient diagnostic facilities include outpatient facilities 
providing radiography, mammography, ultrasonography, 
electrocardiography, magnetic resonance imaging, computerized axial 
tomography, and in vitro testing. An outpatient diagnostic facility may 
be either independent (i.e., not a part of a provider of services or 
any other facility) or operated by another medical entity (e.g., under 
the common ownership, licensure, or control of an entity). An 
outpatient diagnostic facility is covered by this regulation regardless 
of whether it is licensed by a Federal, State, municipal, or local 
government or whether it is accredited by a recognized accreditation 
organization. If an adverse event meets the criteria for reporting, the 
outpatient diagnostic facility must report that event regardless of the 
nature or location of the medical service provided by the outpatient 
diagnostic facility.
    (s) Outpatient treatment facility means a distinct entity that 
operates for the primary purpose of providing nonsurgical therapeutic 
(medical, occupational, or physical) care on an outpatient basis or in 
a home health care setting. Outpatient treatment facilities include 
ambulance providers, rescue services, and home health care groups. 
Examples of services provided by outpatient treatment facilities 
include the following: Cardiac defibrillation, chemotherapy, 
radiotherapy, pain control, dialysis, speech or physical therapy, and 
treatment for substance abuse. An outpatient treatment facility may be 
either independent (i.e., not a part of a provider of services or any 
other facility) or operated by another medical entity (e.g., under the 
common ownership, licensure, or control of an entity). An outpatient 
treatment facility is covered by this regulation regardless of whether 
it is licensed by a Federal, State, municipal, or local government or 
whether it is accredited by a recognized accreditation organization. If 
an adverse event meets the criteria for reporting, the outpatient 
treatment facility must report that event regardless of the nature or 
location of the medical service provided by the outpatient treatment 
facility.
    (t) Patient of the facility means any individual who is being 
diagnosed or treated and/or receiving medical care at or under the 
control or authority of the facility. This includes employees of the 
facility or individuals affiliated with the facility who, in the course 
of their duties, suffer a device-related death or serious injury that 
has or may have been caused or contributed to by a device used at the 
facility.
    (u) Physician's office means a facility that operates as the office 
of a physician or other health care professional for the primary 
purpose of examination, evaluation, and treatment or referral of 
patients. Examples of physician offices include: Dentist offices, 
chiropractor offices, optometrist offices, nurse practitioner offices, 
school nurse offices, school clinics, employee health clinics, or 
freestanding care units. A physician's office may be independent, a 
group practice, or part of a Health Maintenance Organization.
    (v) Remedial action means any action other than routine maintenance 
or servicing of a device where such action is necessary to prevent 
recurrence of a reportable event.
    (w) Serious injury means an injury or illness that:
    (1) Is life-threatening,
    (2) Results in permanent impairment of a body function or permanent 
damage to a body structure, or
    (3) Necessitates medical or surgical intervention to preclude 
permanent impairment of a body function or permanent damage to a body 
structure. Permanent means irreversible impairment or damage to a body 
structure or function, excluding trivial impairment or damage.
    (x) User facility report number means the number that uniquely 
identifies each report submitted by a user facility to manufacturers 
and to us. This number consists of the following three parts:
    (1) The user facility's 10-digit Centers for Medicare and Medicaid 
Services (CMS) number (if the CMS number has fewer than 10 digits, fill 
the remaining spaces with zeros);
    (2) The four-digit calendar year in which the report is submitted; 
and
    (3) The four-digit sequence number of the reports submitted for the 
year, starting with 0001. (For example, a complete user facility report 
number will appear as follows: 1234560000-2011-0001. If a user facility 
has more than one CMS number, it must select one that will be used for 
all of its MDR reports. If a user facility has no CMS number, it should 
use all zeros in the appropriate space in its initial report (e.g., 
0000000000-2011-0001). We will assign a number for future use and send 
that number to the user facility. This number is used in our record of 
the initial report, in subsequent reports, and in any correspondence 
with the user facility. If a facility has multiple sites, the primary 
site may submit reports for all sites and use one reporting number for 
all sites if the primary site provides the name, address, and CMS 
number for each respective site.)
    (y) Work day means Monday through Friday, except Federal holidays.
    (z) [Reserved]


Sec.  803.9  What information from the reports do we disclose to the 
public?

    (a) We may disclose to the public any report, including any FDA 
record of a telephone report, submitted under this part. Our 
disclosures are governed by part 20 of this chapter.
    (b) Before we disclose a report to the public, we will delete the 
following:
    (1) Any information that constitutes trade secret or confidential 
commercial or financial information under Sec.  20.61 of this chapter;
    (2) Any personal, medical, and similar information, including the 
serial number of implanted devices, which would constitute an invasion 
of personal privacy under Sec.  20.63 of this chapter. However, if a 
patient requests a report, we will disclose to that patient all the 
information in the report concerning that patient, as provided in Sec.  
20.61 of this chapter; and
    (3) Any names and other identifying information of a third party 
that voluntarily submitted an adverse event report.
    (c) We may not disclose the identity of a device user facility that 
makes a report under this part except in connection with:
    (1) An action brought to enforce section 301(q) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)), including the failure 
or refusal to furnish material or information required by section 519 
of the Federal

[[Page 8849]]

Food, Drug, and Cosmetic Act (21 U.S.C. 360i));
    (2) A communication to a manufacturer of a device that is the 
subject of a report required to be submitted by a user facility under 
Sec.  803.30; or
    (3) A disclosure to employees of the Department of Health and Human 
Services, to the Department of Justice, or to the duly authorized 
committees and subcommittees of the Congress.


Sec.  803.10  Generally, what are the reporting requirements that apply 
to me?

    (a) If you are a device user facility, you must submit reports 
(described in subpart C of this part), as follows:
    (1) Submit reports of individual adverse events no later than 10 
work days after the day that you become aware of a reportable event:
    (i) Submit reports of device-related deaths to us and to the 
manufacturer, if known, or
    (ii) Submit reports of device-related serious injuries to the 
manufacturers or, if the manufacturer is unknown, submit reports to us.
    (2) Submit annual reports (described in Sec.  803.33) to us.
    (b) If you are an importer, you must submit reports (described in 
subpart D of this part), as follows:
    (1) Submit reports of individual adverse events no later than 30 
calendar days after the day that you become aware of a reportable 
event:
    (i) Submit reports of device-related deaths or serious injuries to 
us and to the manufacturer or
    (ii) Submit reports of device-related malfunctions to the 
manufacturer.
    (2) [Reserved]
    (c) If you are a manufacturer, you must submit reports (described 
in subpart E of this part) to us, as follows:
    (1) Submit reports of individual adverse events no later than 30 
calendar days after the day that you become aware of a reportable 
death, serious injury, or malfunction.
    (2) Submit reports of individual adverse events no later than 5 
work days after the day that you become aware of:
    (i) A reportable event that requires remedial action to prevent an 
unreasonable risk of substantial harm to the public health or
    (ii) A reportable event for which we made a written request.
    (3) Submit supplemental reports if you obtain information that you 
did not submit in an initial report.


Sec.  803.11  What form should I use to submit reports of individual 
adverse events and where do I obtain these forms?

    (a) If you are a manufacturer or importer, you must submit reports 
of individual adverse events to FDA in an electronic format in 
accordance with Sec.  803.12(a) and Sec.  803.20, unless granted an 
exemption under Sec.  803.19.
    (b) Importer reports submitted to device manufacturers may be in 
paper format or an electronic format that includes all required data 
fields to ensure that the manufacturer has all required information.
    (c) If you are a user facility, you must submit reports of 
individual adverse events in accordance with Sec.  803.12(b) and Sec.  
803.20.
    (d) Form FDA 3500A is available on the Internet at http://www.fda.gov/medwatch/getforms.htm or from Division of Small 
Manufacturers, International and Consumer Assistance, Office of 
Communication and Education, Center for Devices and Radiological 
Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD 
20993-0002, by email: DSMICA@fda.hhs.gov, FAX: 301-847-8149, or 
telephone: 800-638-2041.


Sec.  803.12  How do I submit initial and supplemental or followup 
reports?

    (a) Manufacturers and importers must submit initial and 
supplemental or followup reports to FDA in an electronic format that 
FDA can process, review, and archive.
    (b) User facilities that submit their reports and additional 
information to FDA electronically must use an electronic format that 
FDA can process, review, and archive. User facilities that submit their 
reports to FDA on paper must submit any written report or additional 
information required under this part to FDA, CDRH, Medical Device 
Reporting, P.O. Box 3002, Rockville, MD 20847-3002, using Form FDA 
3500A. Each report must be identified (e.g., ``User Facility Report'' 
or ``Annual Report'').
    (c) If you are confronted with a public health emergency, this can 
be brought to FDA's attention by contacting FDA's Office of Crisis 
Management, Emergency Operations Center by telephone, 24-hours a day, 
at 301-796-8240 or toll free at 866-300-4374, followed by the 
submission of an email to: emergency.operations@fda.hhs.gov.

    Note: This action does not satisfy your obligation to report 
under part 803.

    (d) You may submit a voluntary telephone report to the MedWatch 
office at 800-FDA-1088. You may also obtain information regarding 
voluntary reporting from the MedWatch office at 800-FDA-1088. You may 
also find the voluntary Form FDA 3500 and instructions to complete it 
at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm.


Sec.  803.13  Do I need to submit reports in English?

    Yes. You must submit all reports required by this part in English.


Sec.  803.15  How will I know if you require more information about my 
medical device report?

    (a) We will notify you in writing if we require additional 
information and will tell you what information we need. We will require 
additional information if we determine that protection of the public 
health requires additional or clarifying information for medical device 
reports submitted to us and in cases when the additional information is 
beyond the scope of FDA reporting forms or is not readily accessible to 
us.
    (b) In any request under this section, we will state the reason or 
purpose for the information request, specify the due date for 
submitting the information, and clearly identify the reported event(s) 
related to our request. If we verbally request additional information, 
we will confirm the request in writing.


Sec.  803.16  When I submit a report, does the information in my report 
constitute an admission that the device caused or contributed to the 
reportable event?

    No. A report or other information submitted by you, and our release 
of that report or information, is not necessarily an admission that the 
device, or you or your employees, caused or contributed to the 
reportable event. You do not have to admit and may deny that the report 
or information submitted under this part constitutes an admission that 
the device, you, or your employees, caused or contributed to a 
reportable event.


Sec.  803.17  What are the requirements for developing, maintaining, 
and implementing written MDR procedures that apply to me?

    If you are a user facility, importer, or manufacturer, you must 
develop, maintain, and implement written MDR procedures for the 
following:
    (a) Internal systems that provide for:
    (1) Timely and effective identification, communication, and 
evaluation of events that may be subject to MDR requirements;
    (2) A standardized review process or procedure for determining when 
an event meets the criteria for reporting under this part; and
    (3) Timely transmission of complete medical device reports to 
manufacturers or to us, or to both if required.
    (b) Documentation and recordkeeping requirements for:
    (1) Information that was evaluated to determine if an event was 
reportable;

[[Page 8850]]

    (2) All medical device reports and information submitted to 
manufacturers and/or us;
    (3) Any information that was evaluated for the purpose of preparing 
the submission of annual reports; and
    (4) Systems that ensure access to information that facilitates 
timely followup and inspection by us.


Sec.  803.18  What are the requirements for establishing and 
maintaining MDR files or records that apply to me?

    (a) If you are a user facility, importer, or manufacturer, you must 
establish and maintain MDR event files. You must clearly identify all 
MDR event files and maintain them to facilitate timely access.
    (b)(1) For purposes of this part, ``MDR event files'' are written 
or electronic files maintained by user facilities, importers, and 
manufacturers. MDR event files may incorporate references to other 
information (e.g., medical records, patient files, engineering 
reports), in lieu of copying and maintaining duplicates in this file. 
Your MDR event files must contain:
    (i) Information in your possession or references to information 
related to the adverse event, including all documentation of your 
deliberations and decision making processes used to determine if a 
device-related death, serious injury, or malfunction was or was not 
reportable under this part;
    (ii) Copies of all reports submitted under this part (whether paper 
or electronic), and of all other information related to the event that 
you submitted to us or other entities such as an importer, distributor, 
or manufacturer; and
    (iii) Copies of all electronic acknowledgments FDA sends you in 
response to electronic MDR submissions.
    (2) If you are a user facility, importer, or manufacturer, you must 
permit any authorized FDA employee, at all reasonable times, to access, 
to copy, and to verify the records required by this part.
    (c) If you are a user facility, you must retain an MDR event file 
relating to an adverse event for a period of 2 years from the date of 
the event. If you are a manufacturer or importer, you must retain an 
MDR event file relating to an adverse event for a period of 2 years 
from the date of the event or a period of time equivalent to the 
expected life of the device, whichever is greater. If the device is no 
longer distributed, you still must maintain MDR event files for the 
time periods described in this paragraph (c).
    (d)(1) If you are a device distributor, you must establish and 
maintain device complaint records (files). Your records must contain 
any incident information, including any written, electronic, or oral 
communication, either received or generated by you, that alleges 
deficiencies related to the identity (e.g., labeling), quality, 
durability, reliability, safety, effectiveness, or performance of a 
device. You must also maintain information about your evaluation of the 
allegations, if any, in the incident record. You must clearly identify 
the records as device incident records and file these records by device 
name. You may maintain these records in written or electronic format. 
You must back up any file maintained in electronic format.
    (2) You must retain copies of the required device incident records 
for a period of 2 years from the date of inclusion of the record in the 
file or for a period of time equivalent to the expected life of the 
device, whichever is greater. You must maintain copies of these records 
for this period even if you no longer distribute the device.
    (3) You must maintain the device complaint files established under 
this section at your principal business establishment. If you are also 
a manufacturer, you may maintain the file at the same location as you 
maintain your complaint file under part 820 of this chapter. You must 
permit any authorized FDA employee, at all reasonable times, to access, 
to copy, and to verify the records required by this part.
    (e) If you are a manufacturer, you may maintain MDR event files as 
part of your complaint file, under part 820 of this chapter, if you 
prominently identify these records as MDR reportable events. We will 
not consider your submitted MDR report to comply with this part unless 
you evaluate an event in accordance with the quality system 
requirements described in part 820 of this chapter. You must document 
and maintain in your MDR event files an explanation of why you did not 
submit or could not obtain any information required by this part, as 
well as the results of your evaluation of each event.


Sec.  803.19  Are there exemptions, variances, or alternative forms of 
adverse event reporting requirements?

    (a) We exempt the following persons from the adverse event 
reporting requirements in this part:
    (1) A licensed practitioner who prescribes or administers devices 
intended for use in humans and manufactures or imports devices solely 
for use in diagnosing and treating persons with whom the practitioner 
has a ``physician-patient'' relationship;
    (2) An individual who manufactures devices intended for use in 
humans solely for this person's use in research or teaching and not for 
sale. This includes any person who is subject to alternative reporting 
requirements under the investigational device exemption regulations 
(described in part 812 of this chapter), which require reporting of all 
adverse device effects; and
    (3) Dental laboratories or optical laboratories.
    (b) If you are a manufacturer, importer, or user facility, you may 
request an exemption or variance from any or all of the reporting 
requirements in this part, including the requirements of Sec.  803.12. 
You must submit the request to us in writing at the following address: 
MDR Exemption Requests, Office of Surveillance and Biometrics, 10903 
New Hampshire Ave., Bldg. 66, Rm. 3217, Silver Spring, MD 20993-0002. 
Your request must include information necessary to identify you and the 
device; a complete statement of the request for exemption, variance, or 
alternative reporting; and an explanation why your request is 
justified. If you are requesting an exemption from the requirement to 
submit reports to FDA in electronic format under Sec.  803.12(a), your 
request should indicate for how long you will require this exemption.
    (c) If you are a manufacturer, importer, or user facility, we may 
grant in writing an exemption or variance from, or alternative to, any 
or all of the reporting requirements in this part, and may change the 
frequency of reporting to quarterly, semiannually, annually or other 
appropriate time period. We may grant these modifications in response 
to your request, as described in paragraph (b) of this section, or at 
our discretion. When we grant modifications to the reporting 
requirements, we may impose other reporting requirements to ensure the 
protection of public health.
    (d) We may revoke or modify in writing an exemption, variance, or 
alternative reporting requirement if we determine that revocation or 
modification is necessary to protect the public health.
    (e) If we grant your request for a reporting modification, you must 
submit any reports or information required in our approval of the 
modification. The conditions of the approval will replace and supersede 
the regular reporting requirement specified in this part until such 
time that we revoke or modify the alternative reporting requirements in 
accordance with paragraph (d) of this

[[Page 8851]]

section or until the date specified in our response granting your 
variance, at which time the provisions of this part will again apply.

Subpart B--Generally Applicable Requirements for Individual Adverse 
Event Reports


Sec.  803.20  How do I complete and submit an individual adverse event 
report?

    (a) What form must I complete and submit?
    (1) If you are a health professional or consumer or other entity, 
you may submit voluntary reports to FDA regarding devices or other FDA-
regulated products using the Form FDA 3500.
    (2) To submit a mandatory report in written form, a user facility 
must use Form FDA 3500A.
    (3) An electronic submission of a mandatory report from a user 
facility, importer, or manufacturer must contain the information from 
the applicable blocks of Form FDA 3500A. All electronic submissions 
must include information about the patient, the event, the device, and 
the ``initial reporter.'' An electronic submission from a user facility 
or importer must include the information from block F. An electronic 
submission from a manufacturer must include the information from blocks 
G and H. If you are a manufacturer and you receive a report from a user 
facility or importer, you must incorporate that information in your 
electronic submission and include any corrected or missing information.
    (b) To whom must I submit reports and when?
    (1) If you are a user facility, you must submit MDR reports to:
    (i) The manufacturer and to us no later than 10 work days after the 
day that you become aware of information that reasonably suggests that 
a device has or may have caused or contributed to a death or
    (ii) The manufacturer no later than 10 work days after the day that 
you become aware of information that reasonably suggests that a device 
has or may have caused or contributed to a serious injury. If the 
manufacturer is not known, you must submit this report to us.
    (2) If you are an importer, you must submit MDR reports to:
    (i) The manufacturer and to us, no later than 30 calendar days 
after the day that you become aware of information that reasonably 
suggests that a device has or may have caused or contributed to a death 
or serious injury or
    (ii) The manufacturer, no later than 30 calendar days after 
receiving information that a device you market has malfunctioned and 
that this device or a similar device that you market would be likely to 
cause or contribute to a death or serious injury if the malfunction 
were to recur.
    (3) If you are a manufacturer, you must submit MDR reports to us:
    (i) No later than 30 calendar days after the day that you become 
aware of information that reasonably suggests that a device may have 
caused or contributed to a death or serious injury or
    (ii) No later than 30 calendar days after the day that you become 
aware of information that reasonably suggests a device has 
malfunctioned and that this device or a similar device that you market 
would be likely to cause or contribute to a death or serious injury if 
the malfunction were to recur; or
    (iii) Within 5 work days if required by Sec.  803.53.
    (c) What kind of information reasonably suggests that a reportable 
event has occurred?
    (1) Any information, including professional, scientific, or medical 
facts, observations, or opinions, may reasonably suggest that a device 
has caused or may have caused or contributed to an MDR reportable 
event. An MDR reportable event is a death, a serious injury, or, if you 
are a manufacturer or importer, a malfunction that would be likely to 
cause or contribute to a death or serious injury if the malfunction 
were to recur.
    (2) If you are a user facility, importer, or manufacturer, you do 
not have to report an adverse event if you have information that would 
lead a person who is qualified to make a medical judgment reasonably to 
conclude that a device did not cause or contribute to a death or 
serious injury, or that a malfunction would not be likely to cause or 
contribute to a death or serious injury if it were to recur. Persons 
qualified to make a medical judgment include physicians, nurses, risk 
managers, and biomedical engineers. You must keep in your MDR event 
files (described in Sec.  803.18) the information that the qualified 
person used to determine whether or not a device-related event was 
reportable.


Sec.  803.21  Where can I find the reporting codes for adverse events 
that I use with medical device reports?

    (a) The MedWatch Medical Device Reporting Code Instruction Manual 
contains adverse event codes for use with Form FDA 3500A. You may 
obtain the coding manual from FDA's Web site at: http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/default.htm; 
and from the Division of Small Manufacturers, International and 
Consumer Assistance, Center for Devices and Radiological Health, 10903 
New Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD 20993-0002, 
FAX: 301-847-8149, or email to DSMICA@fda.hhs.gov.
    (b) We may sometimes use additional coding of information on the 
reporting forms or modify the existing codes. If we do make 
modifications, we will ensure that we make the new coding information 
available to all reporters.


Sec.  803.22  What are the circumstances in which I am not required to 
file a report?

    (a) If you become aware of information from multiple sources 
regarding the same patient and same reportable event, you may submit 
one medical device report.
    (b) You are not required to submit a medical device report if:
    (1) You are a user facility, importer, or manufacturer, and you 
determine that the information received is erroneous in that a device-
related adverse event did not occur. You must retain documentation of 
these reports in your MDR files for the time periods specified in Sec.  
803.18.
    (2) You are a manufacturer or importer and you did not manufacture 
or import the device about which you have adverse event information. 
When you receive reportable event information in error, you must 
forward this information to us with a cover letter explaining that you 
did not manufacture or import the device in question.


Sec.  803.23  Where can I find information on how to prepare and submit 
an MDR in electronic format?

    (a) You may obtain information on how to prepare and submit reports 
in an electronic format that FDA can process, review, and archive at: 
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.
    (b) We may sometimes update information on how to prepare and 
submit reports electronically. If we do make modifications, we will 
ensure that we alert reporters by updating the eMDR Web page.

Subpart C--User Facility Reporting Requirements


Sec.  803.30  If I am a user facility, what reporting requirements 
apply to me?

    (a) You must submit reports to the manufacturer or to us, or both, 
as specified in paragraphs (a)(1) and (a)(2) of this section as 
follows:
    (1) Reports of death. You must submit a report to us as soon as 
practicable but

[[Page 8852]]

no more than 10 work days after the day that you become aware of 
information, from any source, that reasonably suggests that a device 
has or may have caused or contributed to the death of a patient of your 
facility. You must also submit the report to the device manufacturer, 
if known. You must submit the information required by Sec.  803.32. 
Reports sent to the Agency must be submitted in accordance with the 
requirements of Sec.  803.12(b).
    (2) Reports of serious injury. You must submit a report to the 
manufacturer of the device no later than 10 work days after the day 
that you become aware of information, from any source, that reasonably 
suggests that a device has or may have caused or contributed to a 
serious injury to a patient of your facility. If the manufacturer is 
not known, you must submit the report to us. You must report 
information required by Sec.  803.32. Reports sent to the Agency must 
be submitted in accordance with the requirements of Sec.  803.12 (b).
    (b) What information does FDA consider ``reasonably known'' to me? 
You must submit all information required in this subpart C that is 
reasonably known to you. This information includes information found in 
documents that you possess and any information that becomes available 
as a result of reasonable followup within your facility. You are not 
required to evaluate or investigate the event by obtaining or 
evaluating information that you do not reasonably know.


Sec.  803.32  If I am a user facility, what information must I submit 
in my individual adverse event reports?

    You must include the following information in your report, if 
reasonably known to you, as described in Sec.  803.30(b). These types 
of information correspond generally to the elements of Form FDA 3500A:
    (a) Patient information (Form FDA 3500A, Block A). You must submit 
the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Form FDA 3500A, Block B). You 
must submit the following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event (e.g., death or 
serious injury). An outcome is considered a serious injury if it is:
    (i) A life-threatening injury or illness;
    (ii) A disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
    (iii) An injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of this report;
    (5) Description of event or problem, including a discussion of how 
the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests, including dates and laboratory 
data; and
    (7) Description of other relevant history, including preexisting 
medical conditions.
    (c) Device information (Form FDA 3500A, Block D). You must submit 
the following:
    (1) Brand name;
    (2) Product Code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or 
other identifying number, and expiration date;
    (5) Operator of the device (health professional, lay user/patient, 
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explantation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed 
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and 
reused on a patient (yes to paragraph (c)(8) of this section), the name 
and address of the reprocessor;
    (10) Whether the device was available for evaluation and whether 
the device was returned to the manufacturer; if so, the date it was 
returned to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report 
products that were used to treat the event.)
    (d) Initial reporter information (Form FDA 3500A, Block E). You 
must submit the following:
    (1) Name, address, and telephone number of the reporter who 
initially provided information to you, or to the manufacturer or 
distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to 
us, if known.
    (e) User facility information (Form FDA 3500A, Block F). You must 
submit the following:
    (1) An indication that this is a user facility report (by marking 
the user facility box on the form);
    (2) Your user facility number;
    (3) Your address;
    (4) Your contact person;
    (5) Your contact person's telephone number;
    (6) Date that you became aware of the event (month, day, year);
    (7) Type of report (initial or followup); if it is a followup, you 
must include the report number of the initial report;
    (8) Date of your report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to 
the ``MedWatch Medical Device Reporting Code Instructions'');
    (11) Whether a report was sent to us and the date it was sent 
(month, day, year);
    (12) Location where the event occurred;
    (13) Whether the report was sent to the manufacturer and the date 
it was sent (month, day, year); and
    (14) Manufacturer name and address, if available.


Sec.  803.33  If I am a user facility, what must I include when I 
submit an annual report?

    (a) You must submit to us an annual report on Form FDA 3419. You 
must submit an annual report by January 1, of each year. You may obtain 
this form from the following sources:
    (1) On the Internet at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM080796.pdf or
    (2) Division of Small Manufacturers, International and Consumer 
Assistance, Office of Communication and Education, Center for Devices 
and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, 
Silver Spring, MD 20993-0002, by email: DSMICA@fda.hhs.gov, FAX: 301-
847-8149, or telephone: 800-638-2041.
    (b) You must clearly identify your annual report as such. You must 
submit your annual report to FDA, CDRH, Medical Device Reporting, P.O. 
Box 3002, Rockville, MD 20847-3002. Your annual report must include:
    (1) Your CMS provider number used for medical device reports, or 
the number assigned by us for reporting purposes in accordance with 
Sec.  803.3;
    (2) Reporting year;
    (3) Your name and complete address;
    (4) Total number of reports attached or summarized;
    (5) Date of the annual report and report numbers identifying the 
range of medical device reports that you

[[Page 8853]]

submitted during the report period (e.g., 1234567890-2011-0001 through 
1000);
    (6) Name, position title, and complete address of the individual 
designated as your contact person responsible for reporting to us and 
whether that person is a new contact for you; and
    (7) Information for each reportable event that occurred during the 
annual reporting period including:
    (i) Report number;
    (ii) Name and address of the device manufacturer;
    (iii) Device brand name and common name;
    (iv) Product model, catalog, serial and lot number;
    (v) A brief description of the event reported to the manufacturer 
and/or us; and
    (vi) Where the report was submitted, i.e., to the manufacturer, 
importer, or us.
    (c) In lieu of submitting the information in paragraph (b)(7) of 
this section, you may submit a copy of each medical device report that 
you submitted to the manufacturers and/or to us during the reporting 
period.
    (d) If you did not submit any medical device reports to 
manufacturers or us during the time period, you do not need to submit 
an annual report.

Subpart D--Importer Reporting Requirements


Sec.  803.40  If I am an importer, what reporting requirements apply to 
me?

    (a) Reports of deaths or serious injuries. You must submit a report 
to us, and a copy of this report to the manufacturer, as soon as 
practicable, but no later than 30 calendar days after the day that you 
receive or otherwise become aware of information from any source, 
including user facilities, individuals, or medical or scientific 
literature, whether published or unpublished, that reasonably suggests 
that one of your marketed devices may have caused or contributed to a 
death or serious injury. You must submit the information required by 
Sec.  803.42. Reports sent to the Agency must be submitted in 
accordance with the requirements of Sec.  803.12(a).
    (b) Reports of malfunctions. You must submit a report to the 
manufacturer as soon as practicable but no later than 30 calendar days 
after the day that you receive or otherwise become aware of information 
from any source, including user facilities, individuals, or through 
your own research, testing, evaluation, servicing, or maintenance of 
one of your devices, that reasonably suggests that one of your devices 
has malfunctioned and that this device or a similar device that you 
market would be likely to cause or contribute to a death or serious 
injury if the malfunction were to recur. You must submit the 
information required by Sec.  803.42. Reports to manufacturers may be 
made in accordance with Sec.  803.11(b).


Sec.  803.42  If I am an importer, what information must I submit in my 
individual adverse event reports?

    You must include the following information in your report, if the 
information is known or should be known to you, as described in Sec.  
803.40. These types of information correspond generally to the format 
of Form FDA 3500A:
    (a) Patient information (Form FDA 3500A, Block A). You must submit 
the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Form FDA 3500A, Block B). You 
must submit the following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event (e.g., death or 
serious injury). An outcome is considered a serious injury if it is:
    (i) A life-threatening injury or illness;
    (ii) A disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
    (iii) An injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of this report;
    (5) Description of the event or problem, including a discussion of 
how the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests, including dates and laboratory 
data; and
    (7) Description of other relevant patient history, including 
preexisting medical conditions.
    (c) Device information (Form FDA 3500A, Block D). You must submit 
the following:
    (1) Brand name;
    (2) Product Code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or 
other identifying number, and expiration date;
    (5) Operator of the device (health professional, lay user/patient, 
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explanation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed 
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and 
reused on a patient (yes to paragraph (c)(8) of this section), the name 
and address of the reprocessor;
    (10) Whether the device was available for evaluation, and whether 
the device was returned to the manufacturer, and if so, the date it was 
returned to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report 
products that were used to treat the event.)
    (d) Initial reporter information (Form FDA 3500A, Block E). You 
must submit the following:
    (1) Name, address, and telephone number of the reporter who 
initially provided information to the manufacturer, user facility, or 
distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to 
us, if known.
    (e) Importer information (Form FDA 3500A, Block F). You must submit 
the following:
    (1) An indication that this is an importer report (by marking the 
importer box on the form);
    (2) Your importer report number;
    (3) Your address;
    (4) Your contact person;
    (5) Your contact person's telephone number;
    (6) Date that you became aware of the event (month, day, year);
    (7) Type of report (initial or followup). If it is a followup 
report, you must include the report number of your initial report;
    (8) Date of your report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to 
FDA MedWatch Medical Device Reporting Code Instructions);
    (11) Whether a report was sent to us and the date it was sent 
(month, day, year);
    (12) Location where event occurred;
    (13) Whether a report was sent to the manufacturer and the date it 
was sent (month, day, year); and
    (14) Manufacturer name and address, if available.

[[Page 8854]]

Subpart E--Manufacturer Reporting Requirements


Sec.  803.50  If I am a manufacturer, what reporting requirements apply 
to me?

    (a) If you are a manufacturer, you must report to us the 
information required by Sec.  803.52 in accordance with the 
requirements of Sec.  803.12(a), no later than 30 calendar days after 
the day that you receive or otherwise become aware of information, from 
any source, that reasonably suggests that a device that you market:
    (1) May have caused or contributed to a death or serious injury or
    (2) Has malfunctioned and this device or a similar device that you 
market would be likely to cause or contribute to a death or serious 
injury, if the malfunction were to recur.
    (b) What information does FDA consider ``reasonably known'' to me?
    (1) You must submit all information required in this subpart E that 
is reasonably known to you. We consider the following information to be 
reasonably known to you:
    (i) Any information that you can obtain by contacting a user 
facility, importer, or other initial reporter;
    (ii) Any information in your possession; or
    (iii) Any information that you can obtain by analysis, testing, or 
other evaluation of the device.
    (2) You are responsible for obtaining and submitting to us 
information that is incomplete or missing from reports submitted by 
user facilities, importers, and other initial reporters.
    (3) You are also responsible for conducting an investigation of 
each event and evaluating the cause of the event. If you cannot submit 
complete information on a report, you must provide a statement 
explaining why this information was incomplete and the steps you took 
to obtain the information. If you later obtain any required information 
that was not available at the time you filed your initial report, you 
must submit this information in a supplemental report under Sec.  
803.56 in accordance with the requirements of Sec.  803.12(a).


Sec.  803.52  If I am a manufacturer, what information must I submit in 
my individual adverse event reports?

    You must include the following information in your reports, if 
known or reasonably known to you, as described in Sec.  803.50(b). 
These types of information correspond generally to the format of Form 
FDA 3500A:
    (a) Patient information (Form FDA 3500A, Block A). You must submit 
the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Form FDA 3500A, Block B). You 
must submit the following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event (e.g., death or 
serious injury). An outcome is considered a serious injury if it is:
    (i) A life-threatening injury or illness;
    (ii) A disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
    (iii) An injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of this report;
    (5) Description of the event or problem, including a discussion of 
how the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests, including dates and laboratory 
data; and
    (7) Other relevant patient history including preexisting medical 
conditions.
    (c) Device information (Form FDA 3500A, Block D). You must submit 
the following:
    (1) Brand name;
    (2) Product Code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or 
other identifying number, and expiration date;
    (5) Operator of the device (health professional, lay user/patient, 
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explantation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed 
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and 
reused on a patient (yes to paragraph (c)(8) of this section), the name 
and address of the reprocessor;
    (10) Whether the device was available for evaluation, and whether 
the device was returned to the manufacturer, and if so, the date it was 
returned to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report 
products that were used to treat the event.)
    (d) Initial reporter information (Form FDA 3500A, Block E). You 
must submit the following:
    (1) Name, address, and telephone number of the reporter who 
initially provided information to you, or to the user facility or 
importer;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to 
us, if known.
    (e) Reporting information for all manufacturers (Form FDA 3500A, 
Block G). You must submit the following:
    (1) Your reporting office's contact name and address and device 
manufacturing site;
    (2) Your contact person's telephone number;
    (3) Your report sources;
    (4) Date received by you (month, day, year);
    (5) PMA/510k Number and whether or not the product is a combination 
product;
    (6) Type of report being submitted (e.g., 5-day, initial, 
followup); and
    (7) Your report number.
    (f) Device manufacturer information (Form FDA 3500A, Block H). You 
must submit the following:
    (1) Type of reportable event (death, serious injury, malfunction, 
etc.);
    (2) Type of followup report, if applicable (e.g., correction, 
response to FDA request, etc);
    (3) If the device was returned to you and evaluated by you, you 
must include a summary of the evaluation. If you did not perform an 
evaluation, you must explain why you did not perform an evaluation;
    (4) Device manufacture date (month, day, year);
    (5) Whether the device was labeled for single use;
    (6) Evaluation codes (including event codes, method of evaluation, 
result, and conclusion codes) (refer to FDA MedWatch Medical Device 
Reporting Code Instructions);
    (7) Whether remedial action was taken and the type of action;
    (8) Whether the use of the device was initial, reuse, or unknown;
    (9) Whether remedial action was reported as a removal or correction 
under section 519(f) of the Federal Food, Drug, and Cosmetic Act, and 
if it was, provide the correction/removal report number; and
    (10) Your additional narrative; and/or
    (11) Corrected data, including:
    (i) Any information missing on the user facility report or importer 
report, including any event codes that were not

[[Page 8855]]

reported, or information corrected on these forms after your 
verification;
    (ii) For each event code provided by the user facility under Sec.  
803.32(e)(10) or the importer under Sec.  803.42(e)(10), you must 
include a statement of whether the type of the event represented by the 
code is addressed in the device labeling; and
    (iii) If your report omits any required information, you must 
explain why this information was not provided and the steps taken to 
obtain this information.


Sec.  803.53  If I am a manufacturer, in which circumstances must I 
submit a 5-day report?

    You must submit a 5-day report to us with the information required 
by Sec.  803.52 in accordance with the requirements of Sec.  803.12(a) 
no later than 5 work days after the day that you become aware that:
    (a) An MDR reportable event necessitates remedial action to prevent 
an unreasonable risk of substantial harm to the public health. You may 
become aware of the need for remedial action from any information, 
including any trend analysis or
    (b) We have made a written request for the submission of a 5-day 
report. If you receive such a written request from us, you must submit, 
without further requests, a 5-day report for all subsequent events of 
the same nature that involve substantially similar devices for the time 
period specified in the written request. We may extend the time period 
stated in the original written request if we determine it is in the 
interest of the public health.


Sec.  803.56  If I am a manufacturer, in what circumstances must I 
submit a supplemental or followup report and what are the requirements 
for such reports?

    If you are a manufacturer, when you obtain information required 
under this part that you did not provide because it was not known or 
was not available when you submitted the initial report, you must 
submit the supplemental information to us within 30 calendar days of 
the day that you receive this information. You must submit the 
supplemental or followup report in accordance with the requirements of 
Sec.  803.12(a). On a supplemental or followup report, you must:
    (a) Indicate that the report being submitted is a supplemental or 
followup report;
    (b) Submit the appropriate identification numbers of the report 
that you are updating with the supplemental information (e.g., your 
original manufacturer report number and the user facility or importer 
report number of any report on which your report was based), if 
applicable; and
    (c) Include only the new, changed, or corrected information.


Sec.  803.58  Foreign manufacturers.

    (a) Every foreign manufacturer whose devices are distributed in the 
United States shall designate a U.S. agent to be responsible for 
reporting in accordance with Sec.  807.40 of this chapter. The U.S. 
designated agent accepts responsibility for the duties that such 
designation entails. Upon the effective date of this regulation, 
foreign manufacturers shall inform FDA, by letter, of the name and 
address of the U.S. agent designated under this section and Sec.  
807.40 of this chapter, and shall update this information as necessary. 
Such updated information shall be submitted to FDA, within 5 days of a 
change in the designated agent information.
    (b) U.S.-designated agents of foreign manufacturers are required 
to:
    (1) Report to FDA in accordance with Sec. Sec.  803.50, 803.52, 
803.53, and 803.56;
    (2) Conduct, or obtain from the foreign manufacturer the necessary 
information regarding, the investigation and evaluation of the event to 
comport with the requirements of Sec.  803.50;
    (3) Forward MDR complaints to the foreign manufacturer and maintain 
documentation of this requirement;
    (4) Maintain complaint files in accordance with Sec.  803.18; and
    (5) Register, list, and submit premarket notifications in 
accordance with part 807 of this chapter.


Sec.  803.58  [Amended]

    3. Section 803.58 is stayed indefinitely.

    Dated: February 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03279 Filed 2-13-14; 8:45 am]
BILLING CODE 4160-01-P