Federal Register, Volume 63 Issue 152 (Friday, August 7, 1998)

[Federal Register Volume 63, Number 152 (Friday, August 7, 1998)]
[Proposed Rules]
[Pages 42300-42304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21092]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 806

[Docket No. 98N-0439]

Medical Devices; Reports of Corrections and Removals; Companion
to Direct Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations governing reports of corrections and removals of
medical devices to eliminate the requirement for distributors to make
such reports. This proposed rule is a companion document to the direct
final rule published elsewhere in this issue of the Federal Register.
The amendments are being made to implement provisions of the Federal
Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug
Administration Modernization Act of 1997 (FDAMA). This companion
proposed rule is issued under FDAMA and the act as amended.

DATES: Comments must be received on or before October 21, 1998.
Comments on the information collection requirements must be received on
or before October 6, 1998.

ADDRESSES: Submit written comments on the companion proposed rule to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rosa M. Gilmore, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20857, 301-827-2970.

SUPPLEMENTARY INFORMATION:

I. Background

A. Rulemaking Action

This proposed rule is a companion to the direct final rule
published in the

[[Page 42301]]

final rules section of this issue of the Federal Register. The direct
final rule and this companion proposed rule are substantively
identical. FDA is publishing the direct final rule because the rule
contains noncontroversial changes, and FDA anticipates that it will
receive no significant adverse comment. A detailed discussion of this
rule is set forth in the preamble of the direct final rule. If no
significant comment is received in response to the direct final rule,
no further action will be taken related to this proposed rule. Instead,
FDA will publish a confirmation document within 30 days after the
comment period ends confirming that the direct final rule will go into
effect on December 21, 1998. Additional information about FDA's direct
final rulemaking procedures is set forth in a guidance published in the
Federal Register of November 21, 1997 (62 FR 62466).
If FDA receives any significant adverse comment regarding this
proposed rule, FDA will publish a document withdrawing the direct final
rule within 30 days after the comment period ends and will proceed to
respond to all of the comments under this companion proposed rule using
usual notice-and-comment procedures. The comment period for this
companion proposed rule runs concurrently with the direct final rule's
comment period. Any comments received under this companion proposed
rule will also be considered comments regarding the direct final rule.
A significant adverse comment is defined as a comment that explains
why the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without change. In determining whether a significant adverse comment is
sufficient to terminate a direct final rulemaking, FDA will consider
whether the comment raises an issue serious enough to warrant a
substantive response in a notice-and-comment process. Comments that are
frivolous, insubstantial, or outside the scope of the rule will not be
considered adverse under this procedure. For example, a comment
requesting that device manufacturers report corrections and removals
under part 806 (21 CFR part 806) when a report is required and has
already been submitted under 21 CFR part 803 will not be considered a
significant adverse comment because it is outside the scope of the
rule. In addition, if a significant adverse comment applies to part of
a rule and that part can be severed from the remainder of the rule, FDA
may adopt as final those parts of the rule that are not the subject of
a significant adverse comment.
This action is part of FDA's continuing effort to achieve the
objectives of the President's ``Reinventing Government'' initiative,
and it is intended to reduce the burden of unnecessary regulations on
medical devices without diminishing the protection of public health.

B. Changes Required by FDAMA

FDAMA amended section 519(f) of the act (21 U.S.C. 360i(f)) to
eliminate the requirement that distributors report corrections and
removals. Section 519(f)(1) of the act previously required FDA to
require device manufacturers, distributors, and importers to report
promptly to FDA any correction or removal of a device undertaken : (1)
To reduce a risk to health posed by the device; or (2) to remedy a
violation of the act caused by a device which may present a risk to
health. Section 519(f)(1) of the act also had required that
manufacturers, distributors, and importers keep records of those
corrections and removals that are not required to be reported to FDA.
In accordance with the changes required by FDAMA, the reporting and
recordkeeping requirements relating to corrections and removals have
been eliminated for distributors. The requirements of the statute and
FDA's implementing regulations remain unchanged for manufacturers and
importers. In addition, FDAMA did not change the remaining provisions
of 519(f) of the act. Section 519(f)(2) of the act provides that no
report of a correction or removal action under section 519(f)(1) may be
required if a report of the correction or removal is required and has
been submitted to FDA under section 519(a), which prescribes rules for
reporting and keeping records of certain significant device-related
events. Section 519(f)(3) of the act states that the terms
``correction'' and ``removal'' do not include routine servicing.

C. History of 21 CFR Part 806

In the Federal Register of May 17, 1997 (62 FR 27183), FDA issued a
final rule implementing the reports of corrections and removals
provisions of the Safe Medical Devices Act of 1990, which required
device manufacturers, distributors, and importers to report promptly to
FDA any corrections or removals of a device undertaken to reduce a risk
to health posed by the device or to remedy a violation of the act
caused by the device which may present a risk to health. These
regulations were codified in part 806.
In the Federal Register of December 24, 1997 (63 FR 67274), FDA
announced that it was staying the effective date of the information
collection requirements of part 806 because the information collection
requirements in the final rule had not yet received approval from the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (the PRA). Following OMB's approval of the collection of
information provisions for reports of corrections and removals (see the
Federal Register of February 17, 1998 (63 FR 7811)), FDA published in
the Federal Register of April 16, 1998 (63 FR 18836) a final rule
lifting the stay of effective date and the information collection
requirements became effective May 18, 1998.
On November 21, 1997, the President signed FDAMA into law (Pub. L.
101-115). Section 213 of FDAMA amended section 519(f) of the act by
eliminating ``distributors'' from the reporting requirements of the
reports of corrections and removals provisions of the act. FDAMA did
not change the obligations of device manufacturers and importers, who
continue to be required to comply with the existing reporting and
recordkeeping provisions of the act for corrections and removals.

II. Changes to Part 806--Medical Device; Reports of Corrections and
Removals

Section 519(f)(1) of the act, as amended by section 213 of FDAMA,
no longer requires ``distributors'' to report corrections and removals
of medical devices. Accordingly, the following changes are being
proposed to part 806 to implement the FDAMA provision:
1. Section 806.1 would be amended in paragraphs (a) and (b)(1) by
changing the words ``manufacturers and distributors, including
importers,'' to ``manufacturers and importers.''
2. Section 806.2(f) would be amended by eliminating the definition
of ``distributor'' that included a person who imports devices into the
United States, and replacing that definition of distributor with a
separate definition of ``importer.'' For the purposes of this part,
``importer'' would mean any person who imports a device into the United
States.
3. Section 806.10 would be revised in paragraphs (a), (b), (c),
(c)(2), (c)(4), (d), and (e) to remove the word ``distributor'' each
time it appears.
4. Section 806.20 would be amended in paragraphs (a) and (c) to
remove the words ``importer, or distributor'' each time they appear and
replace them with ``or importer.''

[[Page 42302]]

5. Section 806.30 would be amended to remove the words ``importer,
or distributor'' each time they appear and replace them with ``or
importer.''

III. Environmental Impact

The agency has determined under 21 CFR 25.30(h) that this proposed
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 Impact

FDA has examined the impact of this companion proposed rule under
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612) (as amended by subtitle D of the Small Business Regulatory
Fairness Act of 1996 (Pub. L. 104-121)), and the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs
agencies to assess all costs of available regulatory alternatives and,
when regulatory action 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 this
proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and therefore not subject to review 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. The proposed rule eliminates the reporting
requirements for ``distributors,'' as mandated by FDAMA, thereby
reducing regulatory burdens. The agency, therefore, certifies that this
proposed rule, if issued, will not have a significant economic impact
on a substantial number of small entities. In addition, this proposed
rule will not impose costs of $100 million or more in either the
private sector or State, local, and tribal governments in the
aggregate, and therefore a summary statement of analysis under section
202(a) of the Unfunded Mandates Reform Act is not required.

V. Paperwork Reduction Act of 1995

This proposed 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 below with an estimate of the annual
reporting and recordkeeping burden. Included in the estimate is the
time for reviewing the instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Medical Devices; Reports of Corrections and Removals.
Description: FDA is issuing this proposed rule to amend the
reporting and recordkeeping requirements for corrections and removals
under part 806 to eliminate those requirements for distributors of
medical devices. This amendment implements changes made by FDAMA to
section 519(f) of the act. FDAMA did not amend section 519(f) of the
act with respect to manufacturers and importers. Manufacturers and
importers continue to be subject to the requirements of part 806.
Description of Respondents: Business or other for profit
organizations.
FDA estimates the burden for this collection of information as
follows:

Table 1.--Estimated Annual Reporting Burden^{1
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
806.10 880 1 880 10 8,800
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.--Estimated Annual Recordkeeping Burden^{1
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
806.20 440 1 440 10 4,400
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

The information collection requirements in part 806 prior to this
proposed rule have been approved by OMB and assigned control number
0910-0359. When preparing the earlier package for approval of the
information collection requirements in part 806, FDA reviewed the
reports of corrections and removals submitted in the previous 3 years
under 21 CFR part 7 (the agency's recall provisions). During that
period of time, no reports of corrections or removals were submitted by
distributors. For that reason, FDA did not include distributors among
the respondents estimated in the collection burden for the requirements
previously approved by OMB. Because distributors were not included in
that earlier estimate and because FDAMA now has eliminated requirements
for distributor reporting, FDA has determined that estimates of the
reporting burden for Secs. 806.10 and 806.20 should remain the same.
For consistency with the direct final rule to which this proposed
rule is a companion, FDA is following the PRA comment procedures for
direct final rules in this proposed rule. As provided

[[Page 42303]]

in 5 CFR 1320.5(c)(1), collections of information in a direct final
rule are subject to the procedures set forth in 5 CFR 1320.10.
Interested persons and organizations may, by October 6, 1998, submit to
the Dockets Management Branch (address above) comments on the
information collection provisions of this proposed rule.
At the close of the 60-day comment period, FDA will review the
comments received, revise the information collection provisions as
necessary, and submit these provisions to OMB for review. FDA will
publish a document in the Federal Register when the information
collection provisions are submitted to OMB, and an opportunity for
public comment to OMB will be provided at that time. Prior to the
effective date of the final rule, FDA will publish a document in the
Federal Register of OMB's decision to approve, modify, or disapprove
the information collection provisions. 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.

VI. Comments

Interested persons may, on or before October 21, 1998, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. This comment period runs concurrently with the
comment period for the direct final rule. Two copies of any comments
are to be submitted, except that individuals may submit one copy.
Comments are to be identified with the docket number found in the
brackets in the heading of this document. Received comments may be seen
in the office above between 9 a.m. and 4 p.m., Monday through Friday.
All comments received will be considered comments regarding the direct
final rule and this proposed rule. In the event the direct final rule
is withdrawn, all comments received will be considered comments on this
proposed rule.

List of Subjects in 21 CFR Part 806

Corrections and removals, 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, it is
proposed that 21 CFR part 806 be amended as follows:
1. The part heading for part 806 is revised to read as follows:

PART 806--MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS

2. The authority citation for 21 CFR part 806 continues to read as
follows:

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

3. Section 806.1 is amended by revising paragraphs (a) and (b)(1)
to read as follows:

Sec. 806.1 Scope.

(a) This part implements the provisions of section 519(f) of the
Federal Food, Drug, and Cosmetic Act (the act) requiring device
manufacturers and importers to report promptly to the Food and Drug
Administration (FDA) certain actions concerning device corrections and
removals, and to maintain records of all corrections and removals
regardless of whether such corrections and removals are required to be
reported to FDA.
(b) * * *
(1) Actions taken by device manufacturers or importers to improve
the performance or quality of a device but that do not reduce a risk to
health posed by the device or remedy a violation of the act caused by
the device.
* * * * *
4. Section 806.2 is amended by revising paragraph (f) to read as
follows:

Sec. 806.2 Definitions.

* * * * *
(f) ``Importer'' means, for the purposes of this part, any person
who imports a device into the United States.
* * * * *
5. Section 806.10 is amended by revising paragraphs (a) and (b),
the introductory text of paragraph (c), paragraph (c)(2), and the last
sentence of paragraph (c)(4); and in paragraphs (d) and (e) by removing
the word ``, distributor,'' each time it appears to read as follows:

Sec. 806.10 Reports of corrections and removals.

(a) Each device manufacturer or importer shall submit a written
report to FDA of any correction or removal of a device initiated by
such manufacturer or importer if the correction or removal was
initiated:
(1) To reduce a risk to health posed by the device; or
(2) To remedy a violation of the act caused by the device which may
present a risk to health unless the information has already been
provided as set forth in paragraph (f) of this section or the
corrective or removal action is exempt from the reporting requirements
under Sec. 806.1(b).
(b) The manufacturer or importer shall submit any report required
by paragraph (a) of this section within 10-working days of initiating
such correction or removal.
(c) The manufacturer or importer shall include the following
information in the report:
* * * * *
(2) The name, address, and telephone number of the manufacturer or
importer, and the name, title, address, and telephone number of the
manufacturer or importer representative responsible for conducting the
device correction or removal.
* * * * *
(4) * * * A manufacturer or importer that does not have an FDA
establishment registration number shall indicate in the report whether
it has ever registered with FDA.
* * * * *
6. Section 806.20 is amended by revising paragraphs (a) and (c) to
read as follows:

Sec. 806.20 Records of corrections and removals not required to be
reported.

(a) Each device manufacturer or importer who initiates a correction
or removal of a device that is not required to be reported to FDA under
Sec. 806.10 shall keep a record of such correction or removal.
* * * * *
(c) The manufacturer or importer shall retain records required
under this section for a period of 2 years beyond the expected life of
the device, even if the manufacturer or importer has ceased to
manufacture or import the device. Records required to be maintained
under paragraph (b) of this section must be transferred to the new
manufacturer or importer of the device and maintained for the required
period of time.
7. Section 806.30 is revised to read as follows:

Sec. 806.30 FDA access to records.

Each device manufacturer or importer required under this part to
maintain records and every person who is in charge or custody of such
records shall, upon request of an officer or employee designated by FDA
and under section 704(e) of the act, permit such officer or employee at
all reasonable times to have access to, and to copy and verify, such
records and reports.

[[Page 42304]]

Dated: July 9, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-21092 Filed 8-6-98; 8:45 am]
BILLING CODE 4160-01-F}}