[Federal Register Volume 79, Number 31 (Friday, February 14, 2014)]
[Notices]
[Pages 8977-8978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03276]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0393]
Questions and Answers About Electronic Medical Device Reporting;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Questions and Answers About
eMDR--Electronic Medical Device Reporting.'' FDA has published a final
rule that 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. This guidance provides
general information regarding how to prepare and send an electronic
postmarket medical device report to the Center for Devices and
Radiological Health (CDRH) in FDA. The guidance also identifies where
to find more detailed information on the preparation and transmission
of the reports.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on agency guidance documents are welcome at
any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Questions and Answers About eMDR--Electronic
Medical Device Reporting'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 301-847-8149. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Tahseen Mirza, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2312, Silver Spring, MD 20993-0002, 301-796-7645.
SUPPLEMENTARY INFORMATION:
I. Background
Section 519 of the Federal Food, Drug and Cosmetic Act (the FD&C
Act) (21 U.S.C. 360i) is FDA's authorization to issue a regulation to
require mandatory reporting of device-related adverse events. The
Medical Device Reporting (MDR) regulation, 21 CFR part 803, effective
December 13, 1984, contained reporting requirements for device
manufacturers and importers. Amendments to the FD&C Act under the Safe
Medical Devices Act of 1990 and the Medical Device Amendments of 1992
introduced mandatory reporting by device user facilities and changed
the requirements for device manufacturers, importers and distributors.
FDA revised the MDR regulation (part 803) effective July 31, 1996, to
address the reporting changes. On February 28, 2005, FDA revised the
MDR regulation into plain language.
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. 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. Although FDA encourages user facilities to file reports
electronically, they may continue to use only paper forms for MDR
reporting. The final rule for electronic submission of MDRs to FDA
anticipates that there will be a reduction in costs and time associated
with the submission of MDR reports, elimination of transcription errors
associated with paper reports, and both expedited access to safety
information and enhanced ability to communicate information about
suspected problems. This question and answer guidance provides general
information on how to prepare and send an electronic postmarket medical
device report to FDA and identifies where to find more detailed
information on how to prepare and transmit eMDRs.
The draft eMDR guidance document was published in the Federal
Register of August 21, 2009. No significant comments were received.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on electronic MDR reporting. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute and
regulations.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Questions and Answers about eMDR--
Electronic Medical Device Reporting,'' you may either send an email
request to [email protected] to receive an electronic copy of the
document or send a fax request to 301-847-8149 to receive a hard copy.
Please use the document number 1679 to identify the guidance you are
requesting. A search capability for all CDRH guidance documents is
available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 803 have been approved under
OMB control numbers 0910-0291 and 0910-0437.
[[Page 8978]]
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
Dated: February 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03276 Filed 2-13-14; 8:45 am]
BILLING CODE 4160-01-P