[Federal Register Volume 61, Number 142 (Tuesday, July 23, 1996)]
[Proposed Rules]
[Pages 38348-38352]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 96-18701]



Federal Register / Vol. 61, No. 142 / Tuesday, July 23, 1996 / 
Proposed Rules

[[Page 38348]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803 and 804

[Docket No. 96N-0241]
RIN 0910-AA09


Medical Devices; Reporting; Certification and U.S. Designated 
Agents

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is proposing to revise 
its regulations for medical device manufacturer certification, and to 
issue conforming certification requirements for distributors. FDA is 
also announcing its intent to reconsider the requirement for foreign 
manufacturers to appoint a U.S. designated agent to perform certain 
duties under the adverse event reporting final rule that was published 
in the Federal Register of December 11, 1995. FDA is taking this action 
in response to comments from industry raising concerns that have not 
been addressed previously. Elsewhere in this issue of the Federal 
Register, FDA is announcing a stay of the effective date of the 
manufacturer certification and U.S. designated agent provisions and the 
revocation of the May 28, 1992, distributor certification provisions. 
This proposed rule will assist FDA in protecting the public health by 
helping to ensure that devices are not adulterated or misbranded and 
are safe and effective for their intended uses while reducing the 
regulatory burden on reporting entities.

DATES: Submit written comments by October 7, 1996. FDA intends that any 
final rule based on this proposal become effective 75 days after 
publication of the final rule in the Federal Register.
    Submit written comments on the collection of information 
requirements by August 22, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.
    Submit written comments on the information collection requirements 
to the Office of Information and Regulatory Affairs, Office of 
Management and Budget (OMB), New Executive Office Bldg., 725 17th St. 
NW., rm. 10235, Washington, DC 20503, ATTN: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Earl W. Robinson, Center for Devices 
and Radiological Health (HFZ-530), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-2735.

I. Background

SUPPLEMENTARY INFORMATION: In the Federal Register of December 11, 1995 
(60 FR 63578), FDA published a final rule (parts 803 and 807 (21 CFR 
parts 803 and 807)) requiring medical device user facilities and 
manufacturers to report adverse events related to medical devices under 
a uniform reporting system (hereinafter referred to as the December 
1995 final rule). The December 1995 final rule was scheduled to go into 
effect on April 11, 1996. On April 11, 1996 (61 FR 16043), FDA 
announced that OMB had approved the information collection requirements 
in the final rule; FDA also announced an extension of the effective 
date of the final rule to July 31, 1996. On May 28, 1992, a distributor 
adverse event reporting rule became final. This rule went into effect 
by operation of statute without the benefit of notice and comment.
    After the issuance of the December 1995 final rule, FDA received 
numerous requests for reconsideration of the certification requirements 
and reconsideration of issues relating to U.S. designated agent 
requirements. These comments led FDA to meet with the Health Industry 
Manufacturers Association and several industry representatives on April 
19, May 23, and June 13, 1996. During these meetings, issues concerning 
industry burden and procedures relating to the certification and U.S. 
designated agent requirements were put forth that had not been 
considered previously .
    To allow further consideration of these issues before 
implementation, elsewhere in this issue of the Federal Register, FDA is 
publishing a final rule staying the effective date of the manufacturer 
certification and U.S. designated agent requirements until the agency 
issues a new final rule addressing these issues. This final rule also 
revokes the May 28, 1992, distributor certification provisions to 
provide uniform manufacturer and distributor certification 
requirements.

A. Section 803.57--Annual Certification-

    Section 519(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360i(d)) (the act) provides that each manufacturer, importer, 
and distributor shall certify that it did file a certain number of 
medical device reports (MDR's) in the previous 12 months or it did not 
file any MDR reports. The final rule (Sec. 803.57) required 
manufacturers through their president, chief executive officer 
(C.E.O.), U.S. designated agent of a foreign manufacturer, or other 
official most directly responsible for the firm's operations, to 
certify that they filed MDR's for all reportable events required under 
the rule for the previous 12 months and a numerical summary of MDR's 
that they submitted, or that they did not receive any reportable events 
during the reporting period.
    Industry representatives objected to the corporate status of the 
person required to certify, as well as the content of the certification 
statement itself. Industry representatives objected to requiring the 
C.E.O. or president to certify, because, especially in a large company, 
that person may not be familiar with the details of the MDR reporting 
program. Industry representatives also objected to the requirement that 
they certify that they filed reports for all reportable events during 
the reporting period. Industry representatives objected that this 
requirement was not supported by the language of section 519(d) of the 
act and objected to potential liability that may arise from 
certification that all reportable events had been submitted, if there 
were unintentional reporting mistakes.
    In the December 1995 final rule, FDA required the certification 
that all MDR reportable events were filed on the basis of the statute's 
legislative history. The legislative history of section 519(d) of the 
act states that Congress included this provision on the recommendation 
of the General Accounting Office (GAO) as an important means of 
increasing the effectiveness of the MDR system. (See H. Rept. 808, 
101st Congress, 2d sess. 23, (1990); S. Rept. 513, 101st Congress, 2d 
sess. 26, (1990)). The GAO report noted that certain information 
indicated that a third of the establishments inspected were not even 
aware that the MDR reporting requirements existed (GAO/PEMD-89-10, 
``FDA's Implementation of the Medical Device Reporting Regulation,'' p. 
4). The GAO report recommended certification to ensure that all 
manufacturers and importers be made aware of their obligation to submit 
MDR's and to identify those firms that were not aware of their 
obligation (id. at pp. 5 and 69). The legislative history of section 
519(d) of the act also cites the GAO report recommendation that the 
certification state that the reporter filed a specific number of 
reports and that the firm received or became aware of only these 
reports (H. Rept. 808, 101st Congress, 2d sess. 23).

[[Page 38349]]

    FDA believes that its regulation implementing the certification 
requirements was within the scope of the statutory authority provided 
in section 519(d) of the act. FDA, however, in response to the comments 
objecting to the person required to certify and to the content of the 
certification, has reexamined the certification requirement and 
believes that the regulation may be revised in a manner that will 
address the main concerns raised about the regulation and still meet 
the intent of section 519(d) of the act that will improve MDR 
efficiency by making firms aware of their reporting obligations under 
MDR.
    FDA designated in the December 1995 final rule that the certifier 
must be the president, C.E.O., U.S. designated agent, or other official 
most directly responsible for the firm's operations, in response to a 
comment to the tentative final rule (56 FR 60024, November 26, 1991) 
requesting FDA to identify who should certify. FDA now believes, 
however, based on subsequent comments received, that it may be 
appropriate for someone other than the president or chief executive 
officer to sign the certification statement. FDA believes that the 
proposal suggested by the comments to place this particular 
responsibility of certification with the same individual in whom the 
company has already vested overall responsibility for implementing and 
overseeing its MDR program may be more appropriate than requiring 
certification by the president or C.E.O. FDA, therefore, is proposing 
to revise Sec. 803.57 to provide that the manufacturer shall designate, 
as the certifying official, an individual with oversight 
responsibilities for, and knowledge of, the firm's medical device 
reporting system.
    This proposal also provides that, based upon its organizational 
structure, a firm may designate more than one certifying official, each 
of whom would sign a certification statement for his or her identified 
organizational component or site. This provision is designed to provide 
needed flexibility to large companies with more than one operating 
division or medical device reporting site.
    Regarding the content of the certification, FDA is proposing to 
amend Sec. 803.57 to require that the individual certifying for the 
firm state that: (1) He/she has read the requirements of the MDR 
regulation, (2) the firm has established a system to implement medical 
device reporting; and (3) following the procedures of its medical 
device reporting system, the firm submitted a specified number of 
reports, or no reports, during the certification period.
    FDA believes that this certification statement is a reasonable 
application of the intent of section 519(d) of the act. The legislative 
intent is to improve compliance with the MDR reporting requirements by 
making responsible persons within medical device companies fully aware 
of the MDR reporting requirements. This intent may be reasonably 
accomplished by requiring a responsible company official to certify 
that: (1) He/she has read the MDR regulation, (2) the company has put 
in place a system to implement those regulations, and (3) a specified 
number of MDR reports were submitted during the previous year as a 
result of its implementation system.
    Under proposed Sec. 803.57(a), the dates of certification would 
remain the same as the December 1995 final rule, i.e., the date of the 
firm's annual registration. FDA intends that the first certification 
statement would be due with the first annual registration due at least 
6 months after the effective date of the final rule. For example, if 
the final rule were to become effective in March 1997, the first group 
of certifications would be due with annual registrations due in 
September 1997 and would cover a 6-month period. The next group of 
annual certifications would be due in December 1997 and would cover a 
9-month period. Annual certifications due in April 1998 or later would 
cover a 12-month period. Foreign manufacturers would be required to 
submit their certification with the annual registration, if they 
voluntarily register, or in accordance with the schedule in 
Sec. 807.21(a).

B. Section 803.58--Foreign Manufacturers

    Section 803.58 of the December 1995 final rule required that 
foreign manufacturers designate a U.S. agent to be responsible for 
reporting under part 803. U.S. designated agents were to be responsible 
for: (1) Reporting to FDA in accordance with Secs. 803.50, 803.52, 
803.53, 803.55, and 803.56; (2) conducting, or obtaining from the 
foreign manufacturer, the necessary information regarding the 
investigation and evaluation of the event under the requirements of 
Sec. 803.50; (3) certifying in accordance with Sec. 803.57; (4) 
forwarding MDR complaints to the foreign manufacturer and maintaining 
documentation of this requirement; (5) maintaining complaint files in 
accordance with Sec. 803.18; and (6) registering, listing, and 
submitting premarket notifications in accordance with part 807.
    After the issuance of the December 1995 final rule, manufacturers 
who began to implement arrangements with U.S. designated agents stated 
that it was difficult to find individuals willing to take on the duties 
of a U.S. designated agent and that fees were high for those willing to 
take on the duties. Manufacturers noted particular concern about the 
appropriateness of a U.S. designated agent providing certifications 
related to MDR's and premarket notification requirements because they 
believed that the U.S. designated agent may not be able to accurately 
provide such certifications. Moreover, the potential liability 
associated with certification responsibilities greatly increased the 
cost of U.S. designated agent services.
    In addition to the concerns discussed previously, many other issues 
relating to the implementation and scope of U.S. designated agent 
requirements were raised for the first time after the December 1995 
final rule. After further internal discussions, FDA decided to stay the 
effective date of these requirements, as noted elsewhere in this issue 
of the Federal Register, until further notice and comment proceedings 
and the issuance of a new rule.
    In the interim, foreign manufacturers have a responsibility for 
compliance with all medical device reporting requirements which will 
not be affected by the stay of the effective date of the U.S. 
designated agent requirements. This is because the December 1995 final 
rule contained a significant change regarding foreign manufacturers. 
The original MDR regulation that became effective December 13, 1984, 
applied only to manufacturers that were required to register under part 
807. Because foreign manufacturers are not required to register, the 
1984 rule did not apply to them. The December 1995 final rule, however, 
applies to manufacturers regardless of whether they are required to 
register under part 807. Rather, under Sec. 803.3(n) of the December 
1995 final rule, a manufacturer means any person who manufactures, 
prepares, propagates, compounds, assembles, or processes a device by 
chemical, physical, biological, or other procedure. Accordingly, 
foreign manufacturers clearly fit within the definition of 
manufacturers who are required to submit MDR's under the December 1995 
final rule. Therefore, on July 31, 1996, foreign manufacturers will be 
fully subject to the same requirements of part 803 applicable to 
domestic manufacturers. This includes, but is not limited to, the 
requirements for written procedures (Sec. 803.17), MDR event files 
(Sec. 803.18), individual adverse

[[Page 38350]]

event reports (Secs. 803.50 and 803.52), five-day reports 
(Sec. 803.53), baseline reports (Sec. 803.55), and supplemental reports 
(Sec. 803.56).
    The stayed provisions for U.S. designated agents would have 
required that these functions be performed by a U.S. designated agent 
on behalf of the foreign firm. Because FDA is staying the effective 
date of the U.S. designated agent requirement, the full responsibility 
for reporting is now the obligation of the foreign manufacturer. 
Beginning July 31, 1996, foreign manufacturers are required to submit 
MDR reports directly to FDA (except for certification). In addition, 
existing registration, listing, and premarket notification regulations, 
which will remain in effect during the stay, permit foreign 
manufacturers to register (Sec. 807.40(a)) and submit premarket 
notifications (Sec. 807.81) and require them to list their devices. 
(Sec. 807.40(b)).
     FDA is reconsidering the duties of a U.S. designated agent. As 
noted in the preamble to the December 1995 final rule, FDA intends to 
issue a proposed rule to revoke the reporting requirements for 
distributors, including importers, (part 804 (21 CFR part 804)) and 
replace them with requirements consistent with the new manufacturer and 
user facility reporting requirements under part 803. Because importers 
may be able to play a role, in whole or in part, that was assigned to 
the U.S. designated agent in the December 1995 final rule, FDA believes 
that it would be appropriate to address the issue of U.S. designated 
agents at the same time the agency reproposes requirements for 
distributors and importers generally.
    FDA included the U.S. designated agent requirement in the December 
1995 final rule in order to assure that foreign and domestic 
manufacturers are treated equally and that FDA has access to the same 
information it has from domestic manufacturers that will enable the 
agency to protect the public health. To this end, FDA listed certain 
duties in the December 1995 final rule that a U.S. designated agent 
would be required to perform as described above. FDA solicits comments 
on who may best perform these duties and specifically seeks comments on 
the following points:
    1. What person is best situated to perform the following duties 
that, in the December 1995 final rule, were assigned to the U.S. 
designated agent on behalf of the foreign manufacturer: (1) Reporting 
to FDA in accordance with Secs. 803.50, 803.52, 803.53, 803.55, and 
803.56; (2) conducting, or obtaining from the foreign manufacturer the 
necessary information regarding the investigation and evaluation of the 
event under the requirements of Sec. 803.50; (3) certifying in 
accordance with Sec. 803.57; (4) forwarding MDR complaints to the 
foreign manufacturer and maintaining documentation of this requirement; 
(5) maintaining complaint files in accordance with Sec. 803.18; and (6) 
registering, listing, and submitting premarket notifications in 
accordance with part 807?
    2. Should FDA require a foreign manufacturer to designate a U.S. 
agent to fulfill the role of an ``official correspondent'' with FDA 
regarding MDR reporting and other regulatory issues (e.g., product 
listing)? The intent of this function would be to ensure that FDA can 
easily contact foreign firms on MDR issues and communicate in English 
with them, particularly on urgent public health matters.
    3. Should FDA require foreign manufacturers to designate a U.S. 
agent for the purpose of fulfilling their substantive U.S. MDR 
obligations regarding complaint investigations, reporting, and 
maintenance of MDR files? The intent of this function would be for FDA 
to be able to monitor MDR compliance of foreign firms without 
conducting a costly overseas inspection.
    4. Can either of these functions readily be carried out by 
importers, or by other means, so that foreign manufacturers would not 
be required to enter into contractual arrangements with new entities?
    5. How can these functions be carried out efficiently by foreign 
manufacturers who distribute devices into the United States by multiple 
importers, and how can FDA be routinely informed of all importers of a 
firm annually or on an as needed basis?
    Notwithstanding FDA's intent to repropose these requirements, the 
agency has already tentatively concluded that it should propose that 
two aspects of the U.S. designated agent regulations be deleted. The 
first is the requirement for U.S. designated agents to issue the annual 
certification required under Sec. 803.57. Upon reconsideration, FDA 
believes it is more appropriate for the foreign manufacturer to issue 
this certification as proposed in this rule. The other is the 
requirement for foreign manufacturers to submit premarket notifications 
(510(k)'s) through U.S. designated agents. Although the agency had 
hoped this provision would help resolve 510(k) ownership issues 
regarding foreign manufacturers, FDA is persuaded that the costs 
imposed by this requirement are not likely to outweigh the possible 
benefits. FDA solicits comment on its intent to propose to delete these 
two parts of the U.S. designated agent regulations.

III. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(8) 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.

IV. Analysis of Impacts

    FDA has examined the economic impact of the proposed rule under 
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 
22601-612). Executive Order 12866 directs 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. The 
agency believes that the proposed rule is consistent with the 
principles set out in the Executive Order.
    If a rule has a significant economic impact on a substantial number 
of small entities, the Regulatory Flexibility Act requires agencies to 
analyze regulatory options that would minimize any significant impact 
of the rule on small entities. The proposed rule would apply to all 
medical device manufacturers and distributors whose devices are sold in 
the United States. The proposed rule would relieve two regulatory 
burdens. It would allow the certification statement to be signed by the 
person most familiar with the MDR program, not necessarily the 
president or C.E.O. It also changes the certification statement to 
minimize the possibility of liability as a result of an unintended 
mistake in reporting. Therefore, under the Regulatory Flexibility Act, 
5 U.S.C. 2605(b), the Commissioner of Food and Drugs certifies that the 
proposed rule, if finalized, will not have a significant economic 
impact on a substantial number of small entities.

V. Paperwork Reduction Act of 1995

    This proposed rule contains information collections which are 
subject to review by OMB under the Paperwork Reduction Act of 1995 
(Pub. L. 104-13). The title, description, and respondent description of 
the information collections are shown below along with an estimate of 
the annual record keeping and periodic reporting burden. Included in 
the estimate is the time for reviewing

[[Page 38351]]

instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    Title: Reporting and record keeping requirements for user 
facilities, distributors, and manufacturers of medical devices under 
the Safe Medical Devices Act of 1990 and the Medical Device Amendments 
of 1992 (General Requirements).
    Description: This regulation proposes to amend regulations 
regarding device manufacturer and distributor reporting of deaths, 
serious injuries, and certain malfunctions related to medical devices. 
The purpose of these changes is to improve the protection of the public 
health while also reducing the regulatory burden on reporting entities. 
The rule amends information collection requirements which have been 
approved under OMB no. 0910-0059.
    Description of Respondents: Businesses or other for profit 
organizations, nonprofit organizations, Federal, State, and local 
governments.

                                   TABLE 1.--ESTIMATED ANNUAL REPORTING BURDEN                                  
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
803.57                             12,000               1          12,000               1          12,000       
804.30                              8,200               1           8,200               1           8,200       
Total                              20,200                          20,000                          20,200       
----------------------------------------------------------------------------------------------------------------

    There are no capital or operating and maintenance costs expected as 
a result of this proposal.
    Under OMB information collection no. 0910-0059, which expires on 
February 28, 1999, a total of 187,610 burden hours were approved for 
collection of information requirements in the December 11, 1995, final 
rule (60 FR 63578) on medical device user facility and manufacturer 
reporting, certification and registration. The 12,000 burden hours 
reported above in Table 1 for Sec. 803.57 were included in that 
approval and therefore do not affect the total number of approved 
burden hours. However, the 8,200 burden hours reported in Table 1 for 
Sec. 804.30 have not previously been considered in an information 
collection submission to OMB, and do represent an increase in the 
burden. Therefore, this proposed rule would add 8,200 hours to the 
existing approved burden and would result in a proposed total annual 
information collection burden of 195,810 hours (187,610 + 8,200 = 
195,810).
    Therefore, the agency solicits public comments on the revised 
information collection requirements in order to: (1) Evaluate whether 
the proposed collection of information is necessary for the proper 
performance of the functions of the agency, including whether the 
information will have practical utility; (2) evaluate the accuracy of 
the agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) enhance the quality, utility, and clarity of the information 
to be collected; and (4) minimize the burden of the collection of 
information on those who are to respond, including through the use of 
appropriate automated, electronic, mechanical, or other technological 
collection techniques or other forms of information technology, e.g., 
permitting electronic submission of responses.
    As required by section 3507(d) of the Paperwork Reduction Act of 
1995, FDA has submitted a copy of the proposed rule amending parts 803 
and 804 to OMB for its review of the revised information collection 
requirements. Other organizations and individuals interested in 
submitting comments regarding this burden estimate or any aspect of 
these information collection requirements, including suggestions for 
reducing the burden, should direct them to the Office of Information 
and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. 
NW., rm. 10235, Washington, DC 20503, ATTN: Desk Officer for FDA. 
Written comments on the information collections should be submitted by 
August 22, 1996.

List of Subjects in 21 CFR Parts 803 and 804

    Imports, Medical devices, Reporting and record keeping 
requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 803 and 804 amended as follows:

PART 803--MEDICAL DEVICE REPORTING

    1. The authority citation for part 803 continues to read as 
follows:

    Authority: Secs. 502, 510, 519, 520, 701, 704 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 360j, 371, 
374).

    2. Section 803.1 is amended by revising paragraph (a) to read as 
follows:-


Sec. 803.1  Scope.

    (a) This part establishes requirements for medical device 
reporting. Under this part, medical device user facilities and 
manufacturers must report deaths and serious injuries to which a device 
has or may have caused or contributed, and manufacturers must also 
report certain device malfunctions. Additionally, user facilities and 
manufacturers must establish and maintain adverse event files, and must 
submit to FDA specified followup and summary reports. These reports 
will assist FDA in protecting the public health by helping to ensure 
that devices are not adulterated or misbranded and are safe and 
effective for their intended use.
* * * * *
    3. Section 803.57 is revised to read as follows:


Sec. 803.57  Annual certification.

    (a) All manufacturers required to report under this section shall 
submit an annual certification report to FDA, on FDA Form 3381, or 
electronic equivalent as approved under Sec. 803.14. The date for 
submission of certification coincides with the date for the firm's 
annual registration, as designated in Sec. 807.21 of this chapter. 
Foreign manufacturers shall submit their certification by the date on 
which they would be required to register under Sec. 807.21 of this 
chapter if they were domestic manufacturers. The certification period 
will be the 12-month period ending 1 month before the certification 
date.
    (b) The manufacturer shall designate, as the certifying official, 
an individual with oversight responsibilities for, and knowledge of, 
the firm's medical device reporting system. A manufacturer may 
determine, based upon its organizational structure, that one individual 
cannot oversee or have

[[Page 38352]]

complete knowledge of the operation of the reporting system at all 
organizational components or manufacturing sites owned by the firm. In 
this circumstance, the firm may designate more than one certifying 
official, each of whom will sign a certification statement pertaining 
to their respective identified organizational component(s) or site(s).
    (c) The report shall contain the following information:
    (1) Name, address, telephone number, and FDA registration number or 
FDA---assigned identification number of the reporting site and whether 
the firm is a manufacturer;
    (2) Name, title, address, telephone number, signature, and date of 
signature of the person making the certification;
    (3) Name, address, and FDA registration number of each 
manufacturing site covered by the certification and the number of 
reports submitted for devices manufactured at each site;
    (4) A statement certifying that:
    (i) The individual certifying for the firm has read the MDR 
requirements under part 803;
    (ii) The firm has established a system to implement medical device 
reporting; and
    (iii) Following the procedures of its medical device reporting 
system, the reporting site submitted the specified number of reports, 
or no reports, during the 12-month certification period.
    (d) The name of the manufacturer and the registration number 
submitted under paragraph (c)(1) of this section shall be the same as 
the reporting site that submitted the reports required by Secs. 803.52, 
803.53 and 803.55. Multi-reporting site manufacturers who choose to 
certify centrally must identify the reporting sites, by registration 
number or FDA-assigned identification number and name covered by the 
certification, and provide the information required by paragraph (c)(2) 
and (c)(3) of this section for each reporting site.

PART 804--MEDICAL DEVICE DISTRIBUTOR REPORTING

    4. The authority citation for part 804 continues to read as 
follows:

    Authority: Secs. 502, 510, 519, 520, 701, 704 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 360j, 371, 
374).

    5. Part 804 is amended by adding new Sec. 804.30 to read as 
follows:


Sec. 804.30  Annual certification.

    (a) Distributors required to report under this section shall submit 
an annual certification report to FDA on form FDA 3381, or electronic 
equivalent as approved under Sec. 803.14 of this chapter. The date for 
submission of certification coincides with the date for the firm's 
annual registration as designated in Sec. 807.21 of this chapter. This 
certification period will be the 12-month period ending 1 month before 
the certification date.
    (b) The distributor shall designate, as the certifying official, an 
individual with oversight responsibilities for, and knowledge of, the 
firm's medical device reporting system. A distributor may determine, 
based upon its organizational structure, that one individual cannot 
oversee or have complete knowledge of the operation of the reporting 
system at all organizational components or distribution sites owned by 
the firm. In this circumstance, the firm may designate more than one 
certifying official (one for each component or site), each of whom will 
sign a certification statement pertaining to their respective 
identified organizational component(s) or site(s).
    (c) The report shall contain the following information:
    (1) Name, address, telephone number, and FDA registration number or 
FDA assigned identification number of the firm;
    (2) Name, title, address, telephone number, signature, and date of 
signature of the person making the certification;
    (3) Name, address, and FDA registration number of the distributor 
covered by the certification and the number of reports submitted for 
devices distributed by the distributor;
    (4) A statement certifying that;
    (i) The individual certifying for the firm has read the MDR 
requirements under part 804;
    (ii) The firm has established a system to implement medical device 
reporting; and,
    (iii) Following the procedures of its medical device reporting 
system, the firm submitted the specified number of reports, or no 
reports, during the 12-month certification period.

    Dated: July 16, 1996.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 96-18701 Filed 7-19-96; 2:26 pm]
BILLING CODE 4160-01-F