[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 Burden1                                  
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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806.10                                880               1             880              10           8,800       
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                Table 2.--Estimated Annual Recordkeeping Burden1                                
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                                                      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