[Federal Register Volume 63, Number 152 (Friday, August 7, 1998)]
[Rules and Regulations]
[Pages 42229-42233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21091]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations that govern reports of corrections and removals of medical 
devices to eliminate the requirement for distributors to make such 
reports. The amendments are being made to implement provisions of the 
Federal Food, Drug, and Cosmetic Act (the act),

[[Page 42230]]

as amended by the Food and Drug Administration Modernization Act of 
1997 (FDAMA). FDA is publishing these amendments in accordance with its 
direct final rule procedures. Elsewhere in this issue of the Federal 
Register, FDA is publishing a companion proposed rule under FDA's usual 
procedures for notice and comment to provide a procedural framework to 
finalize the rule in the event the agency receives any significant 
adverse comment and withdraws the direct final rule.

DATES: The regulation is effective December 21, 1998. Submit written 
comments on or before October 21, 1998. Submit written comments on the 
information collection provisions on or before October 6, 1998. If FDA 
receives no significant adverse comment within the specified comment 
period, the agency intends to publish a document confirming the 
effective date of the final rule in the Federal Register within 30 days 
after the comment period on this direct final rule ends.

ADDRESSES: Submit written comments on the direct final 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. 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) of the 
act 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.

B. History of 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 (Pub. L. 101-629), 
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 at part 806 (21 CFR 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 February 17, 1998 (63 FR 7811)), FDA published a final 
rule in the Federal Register of April 16, 1998 (63 FR 18836) 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. 
105-115). 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 Devices; 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 made 
to part 806 to implement the FDAMA provision:
    1. Section 806.1 has been 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) has been 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'' means any person who imports a device into the United 
States.
     3. Section 806.10 has been 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 has been amended in paragraphs (a) and (c) to 
remove the words ``importer, or distributor'' each time they appear and 
replace them with ``or importer.''
    5. Section 806.30 is amended to remove the words ``importer, or 
distributor'' each time they appear and replace them with ``or 
importer.''

III. Rulemaking Action

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA 
described when and how it will employ direct final rulemaking. FDA 
believes that this rule is appropriate for direct final rulemaking 
because FDA views this rule as making noncontroversial amendments to an 
existing regulation, incorporating amendments to section 519(f) of the 
act made by FDAMA, and FDA anticipates no significant adverse comment. 
Consistent with FDA's procedures on direct final rulemaking, FDA is 
publishing elsewhere in this issue of the Federal Register a companion 
proposed rule to amend 21 CFR part 806. The companion proposed rule is 
substantively identical to the direct final rule. The companion 
proposed rule provides a procedural framework within which the rule may 
be finalized in the event the direct final rule is withdrawn because of 
any significant adverse comment. The comment period for the direct 
final rule runs concurrently with the comment period for the companion 
proposed rule. Any comments received under the companion proposed rule 
will be

[[Page 42231]]

considered as comments regarding the direct final rule.
    FDA is providing a comment period on the direct final rule of 75 
days after August 7, 1998. If the agency receives any significant 
adverse comment, FDA intends to withdraw this final rule by publication 
of a document in the Federal Register within 30 days after the comment 
period ends. 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 significant or adverse under this 
procedure. For example, a comment requesting that device manufacturers 
report corrections and removals under 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.
    If FDA withdraws the direct final rule, all comments received will 
be considered under the companion proposed rule in developing a final 
rule using the agency's usual notice-and-comment procedures under the 
Administrative Procedure Act (5 U.S.C. 552 et seq.). If FDA receives no 
significant adverse comment during the specified comment period, FDA 
intends to publish a confirmation document in the Federal Register 
within 30 days after the comment period ends confirming that the direct 
final rule will go into effect on December 21, 1998.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) 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.

V. Analysis of Impacts

    FDA has examined the impact of this direct final 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 direct 
final rule is consistent with the regulatory philosophy and principles 
identified in the Executive Order. In addition, this direct final rule 
is not a significant regulatory action as defined by the Executive 
Order and so is 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 rule eliminates the reporting requirements for 
``distributors,'' as mandated by FDAMA, thereby reducing regulatory 
burdens. The agency certifies that this direct final rule will not have 
a significant economic impact on a substantial number of small 
entities. This direct final rule also does not trigger the requirement 
for a written statement under section 202(a) of the Unfunded Mandates 
Reform Act because it does not impose a mandate that results in an 
expenditure of $100 million or more by State, local or tribal 
governments in the aggregate, or by the private sector, in any 1 year.

VI. Paperwork Reduction Act of 1995

    The direct final rule contains information collection provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (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 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) 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 operating and maintenance costs or capital costs associated with this information collection.  


[[Page 42232]]


                                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        Response        Response                   
----------------------------------------------------------------------------------------------------------------
806.20                                440               1             440              10           4,400       
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\1\ There are no operating and maintenance costs or capital costs associated with this information collection.  

    The information collection requirements in part 806 prior to this 
direct final 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.
    As provided 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 submit comments on 
the information collection requirements of this direct final rule by 
October 6, 1998 to the Dockets Management Branch (address above).
    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 direct 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.

VII. Comments

    Interested persons may on or before October 21, 1998, submit 
written comments regarding this rule to the Dockets Management Branch 
(address above). This comment period runs concurrently with the comment 
period for the companion proposed 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 proposed 
rule and this direct final rule. In the event the direct final rule is 
withdrawn, all comments received regarding the companion proposed rule 
and the direct final rule will be considered comments on the 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, 21 CFR 
part 806 is 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,

[[Page 42233]]

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.

    Dated: July 9, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-21091 Filed 8-6-98; 8:45 am]
BILLING CODE 4160-01-F