[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]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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
created.
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
refinalized.
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:
PART 803--MEDICAL DEVICE REPORTING
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND DISTRIBUTORS OF DEVICES
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.
PART 804--MEDICAL DEVICE DISTRIBUTOR REPORTING
2. The authority citation for 21 CFR 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).
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]
BILLING CODE 4160-01-F
