[Federal Register Volume 61, Number 142 (Tuesday, July 23, 1996)]
[Rules and Regulations]
[Pages 38346-38347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18700]

[[Page 38345]]


Part III

Department of Health and Human Services


Food and Drug Administration


21 CFR Part 803, et al.

Medical Devices; Final and Proposed Rules

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

[[Page 38346]]


Food and Drug Administration

21 CFR Parts 803, 804, and 807

[Docket No. 91N-0295]-
RIN 0910-AA09

Medical Devices; Medical Device Distributor and Manufacturer 
Reporting; Certification, Registration, Listing, and Premarket 
Notification Submission; Stay of Effective Date; Revocation of Final 

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.


SUMMARY: In response to numerous requests for the Food and Drug 
Administration (FDA) to consider further comments concerning medical 
device reporting (MDR) certification and U.S. designated agent 
requirements, FDA is staying the effective date of these two specific 
provisions of the adverse event reporting final rule that was published 
in the Federal Register of December 11, 1995. Specifically, these 
provisions relate to manufacturer certification and U.S. designated 
agent requirements. In addition, for consistency purposes, FDA is 
revoking the distributor reporting certification requirement that went 
into effect on May 28, 1992.

EFFECTIVE DATE: July 23, 1996.

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.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 11, 1995 
(60 FR 63578), FDA published a final rule amending parts 803 and 807 
(21 CFR parts 803 and 807) to require medical device manufacturers, 
including U.S. designated agents of foreign manufacturers, to report 
adverse events related to medical devices under a uniform reporting 
system (hereinafter referred to as the December 1995 final rule). This 
rule also required U.S. designated agents to register, list, and submit 
premarket notifications on behalf of foreign manufacturers. The 
effective date of this rule was to be April 11, 1996. On April 11, 1996 
(61 FR 16043), FDA extended the effective date to July 31, 1996.
    Earlier, in the Federal Register of September 1, 1993 (58 FR 
46514), FDA published a notice announcing that the distributor 
reporting requirements, including certification, that were published as 
a tentative final rule on November 26, 1991, became effective by 
operation of law on May 28, 1992.
    After issuing the December 1995 final rule, FDA received numerous 
requests for reconsideration of the certification requirements and for 
reconsideration of issues relating to U.S. designated agent 
requirements. These comments led FDA to meet with the Health Industry 
Manufacturers Association (HIMA) and several industry representatives 
on April 19, May 23, and June 13, 1996. During these meetings, issues 
concerning industry burdens and procedures relating to the 
certification and U.S. designated agent requirements were put forth 
that had previously not been fully considered.
    Section 519(d) of the act (21 U.S.C. 360i(d)) states that each 
manufacturer and distributor required to make reports under section 
519(a) (21 U.S.C. 360i(a)) of the act must submit annual statements 
certifying the number of reports that were filed or that no reports 
were filed during the previous 12-month period. The certification 
regulations for manufacturers and distributors require that the 
certification include the number of MDR's filed during the previous 12-
month period and that all MDR reportable events have been submitted 
(Secs. 803.57 and 804.30 (21 CFR 804.30)). FDA required the 
certification that all MDR reportable events were filed on the basis of 
legislative history citing the General Accounting Office report 
recommending that certification state that the reporter ``filed a 
specific number of reports * * * and that the firm received or became 
aware of information concerning only these events.'' (H. Rept. 808, 
101st Cong., 2d sess., 23 (1990).) FDA, in response to comments asking 
who should certify for manufacturers, also required in the December 
1995 final rule that the certifier must be the president, chief 
executive officer, U.S. designated agent of a foreign manufacturer, or 
other official most directly responsible for the firm's operations.
    After the final rule was issued, FDA received comments taking the 
position that the certifier may more appropriately be a person with 
more direct involvement with the reporting requirements. Comments also 
objected to requiring that the reporter certify all reportable events 
have been filed on the basis that such a requirement was not 
specifically required in the act, and that potential liability would be 
    The December 1995 final rule also required that foreign firms 
identify a U.S. designated agent who would be responsible for the 
foreign firm's MDR reporting requirements, as well as the foreign 
manufacturer's registration listing and premarket notification 
submissions. After issuing the December 1995 final rule, FDA received 
comments from industry objecting to these requirements as being unduly 
burdensome. In response to these comments, FDA is publishing a proposed 
rule, elsewhere in this issue of the Federal Register, addressing the 
certification and U.S. designated agent issues. FDA intends that the 
requirements relating to distributor and manufacturer certification, 
and to U.S. designated agents, will not be in effect until at least 75 
days after the date of publication in the Federal Register of a new 
final rule.
    The Administrative Procedure Act (Pub. L. 79-404) and FDA 
regulations provide that the agency may issue a regulation without 
notice and comment procedures when the agency for good cause finds (and 
incorporates the finding and a brief statement of reasons thereof in 
the rules issued) that notice and public procedure thereon are 
impracticable, unnecessary, or contrary to the public interest (5 
U.S.C. 553(b)(8); Sec. 10.40(e)(1) (21 CFR 10.40 (e)(1)).) FDA finds 
that there is good cause for dispensing with notice and comment 
procedures to stay the effective date of the manufacturer certification 
and U.S. designated agent reporting provisions, (Secs. 803.3(n)(4), 
803.57, 803.58, 807.3(r), 807.20(a)(6), and 807.40) and for revoking 
the certification requirements for distributors (Sec. 804.30) because 
such notice and comment procedures are impracticable and contrary to 
the public interest.
    Notice and comment rulemaking on the postponement of manufacturer 
certification and U.S.designated agent requirements is impracticable. 
FDA was not aware of a number of significant issues relating to these 
requirements until after publication of the December 1995 final rule. 
Since that time, FDA has had numerous meetings with HIMA and industry 
representatives and internal meetings to decide the best approach to 
understand and resolve issues concerning the rule. The last meeting 
with HIMA and industry representatives occurred on June 13, 1996. 
Without the issuance of a stay under good cause procedures, the 
certification and U.S. designated agent requirements would become 
effective on July 31, 1996.
    In addition, notice and comment rulemaking, in this instance, on 
the stay of the present certification requirements would be contrary to 
the public interest. Because there is not enough time to allow notice 
and comment on the issue

[[Page 38347]]

of staying the effective date before it occurs, the certification and 
U.S. designated agent requirements would be in effect only for the 
interim period between the effective date of the final manufacturer 
rule, July 31, 1996, and the date the agency expects that these 
provisions, after issuance of a reproposed rule, would be revised and 
become final a second time. This result would cause industry to 
implement costly certification and U.S. designated agent procedures and 
contractual arrangements that would most likely have to be changed with 
additional cost after these requirements are reproposed and 
    It is also against the public interest to have a certification 
requirement in effect for distributors, while not having such a 
requirement in effect for manufacturers. The MDR system is intended to 
operate as a uniform reporting system where user facilities, 
distributors, and manufacturers efficiently share, forward, and provide 
complementary information on the same adverse events. Having a system 
whereby distributors certify reports and manufacturers do not certify 
reports would hinder the uniformity of this program and result in 
regulatory confusion.
    For all the reasons stated above, FDA concludes, under 5 U.S.C. 
553(b)(8) and Sec. 10.40(e)(1), that there is good cause for staying 
the effective date of the certification and U.S. designated agent 
provisions of the December 1995 final rule and for revoking the 
distributor certification requirements of the May 28, 1992 rule.
    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 medical device 
reporting regulation that became effective December 13, 1984, defined a 
manufacturer who was required to submit MDR reports as any person who 
is required to register under part 807. Because foreign manufacturers 
are not required to register, the December 1984 regulation did not 
apply to them. The revised December 1995 final rule, however, no longer 
defines a manufacturer who is required to report adverse events as a 
person who is 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. This means that, on July 31, 1996, foreign 
manufacturers will be fully subject to the same requirements of part 
803 applicable to all 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 event reports 
(Secs. 803.50 and 803.52), 5-day reports (Sec. 803.53), baseline 
reports (Sec. 803.55), and supplemental reports (Sec. 803.56). In 
addition, existing regulations will remain in effect pending the stay 
that permits 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)).

List of Subjects

21 CFR parts 803 and 804

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR part 807

    Confidential business information, 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 parts 
803, 804, and 807 are amended as follows:



    1. In the revision of part 803 and the amendments to part 807 which 
were published at 60 FR 63578 (December 11, 1995), the effective date 
of which was extended until July 31, 1996, at 61 FR 16043 (April 11, 
1996), the following provisions are stayed until further notice:

    A. Secs. 803.3(n)(4), 803.57, and 803.58.
    B. The addition of Sec. 807.3(r) and 807.20(a)(6); and
    C. The revision of Sec. 807.40.


    2. The authority citation for 21 CFR part 804 continues to read as 

    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).

Sec. 804.30   [Removed]

    3. Section 804.30 is removed.

    Dated: July 16, 1996.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 96-18700 Filed 7-19-96; 2:26 pm]