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

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

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806.20 440 1 440 10 4,400

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\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

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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.

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Dated: July 9, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98-21092 Filed 8-6-98; 8:45 am]

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