Medical Devices; Reports of Corrections and Removals

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.

-----------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------

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 operating and maintenance costs or capital costs associated with this information collection.

[[Page 42232]]

Table 2.--Estimated Annual Recordkeeping Burden1

----------------------------------------------------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------

\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