Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 807

[Docket No. 98N-0520]

Medical Devices; Establishment Registration and Device Listing

for Manufacturers and Distributors of Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending certain

regulations governing establishment registration and device listing by

domestic distributors. These amendments are being made to implement

revisions to the Federal Food, Drug, and Cosmetic Act (the act), as

amended by the Food and Drug Modernization Act of 1997 (FDAMA).

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 February 11, 1999. Submit written

comments on or before December 14, 1998. If FDA receives no significant

adverse comments 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. If FDA 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. These provisions of FDAMA became effective on February 19,

1998.

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: Walter W. Morgenstern, Center for

Devices and Radiological Health (HFZ-305), Food and Drug

Administration, 2094 Gaither Rd., Rockville, MD 20857, 301-594-4699.

SUPPLEMENTARY INFORMATION:

I. Background

On November 21, 1997, the President signed FDAMA into law (Pub. L.

105-115). Section 213(b) of FDAMA made the following changes to section

510(g) of the act (21 U.S.C. 360(g)) regarding domestic distributor

registration and device listing:

1. FDAMA amended section 510(g) of the act to add a new paragraph

(g)(4) to provide that the registration and listing requirements of

section 510 of the act do not apply to distributors who act as

``wholesale distributor,'' and who do not manufacture, repackage,

process, or relabel a device.

2. FDAMA also added a definition of ``wholesale distributor'' to

section 510(g) of the act. A ``wholesale distributor'' is defined as

``any person (other than the manufacturer or the initial importer) who

distributes a device from the original place of manufacture to the

person who makes the final delivery or sale of the device to the

ultimate consumer or user.''

Section 213 of FDAMA became effective on February 19, 1998, and

FDA is implementing the statute as of that date. FDA is issuing this

direct final rule to amend certain existing regulations to conform to

amendments made by FDAMA to section 510(g) of the act.

II. Amendment Highlights

Section 807.3 (21 CFR 807.3) has been amended to incorporate the

new definitions of distributor and wholesale distributor provided in

amended section 510(g) of the act.

FDA is also amending Sec. 807.3(g) to add a definition for

``initial importer,'' because ``initial importer'' is excluded from the

definition of wholesale distributor established by FDAMA.

Sections 807.20 and 807.22 (21 CFR 807.20 and 807.22) have been

amended to implement the changes made by FDAMA to section 510(g) of the

act. These amendments to 21 CFR part 807 exempt distributors of

domestic or imported devices from the requirement of establishment

registration and device listing. Section 807.20 is further amended to

clarify that initial importers of devices continue to be subject to

registration and listing.

Sections 807.3, 807.20, and 807.22 have been amended to conform the

activities requiring registration with the changes made by FDAMA. Prior

to FDAMA, all distributors were required to register and list. Amended

section 510(g) of the act exempts wholesale distributors from

registration and listing and defines a ``wholesale distributor'' as any

person, other than the manufacturer or initial importer, who

distributes a device from the original place of manufacture to the

person who makes the final delivery or sale of the device to the

ultimate consumer or user. The amendments to Secs. 807.3, 807.20, and

807.22 reflect the changes made by FDAMA.

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. The rule incorporates amendments to section 510(g)

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 certain existing regulations governing

establishment registration and device listing by domestic distributors.

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 of the companion proposed rule. Any comments received

under the companion proposed rule will be considered as comments

regarding the direct final rule.

FDA is providing a comment period on the direct final rule of

December 14, 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

[[Page 51826]]

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 recommending an additional

change to the rule will not be considered a significant adverse

comment, unless the comment states why the rule would be ineffective

without the additional change. 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 under the 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. FDA intends to make the

direct final rule effective February 11, 1999.

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 and benefits 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 codifies applicable statutory requirements

imposed by FDAMA. Because the rule exempts certain distributors from

registration and device listing, it may permit more small competitors

to enter the marketplace. 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

This direct final rule contains no collections of information.

Therefore, clearance by the Office of Management and Budget under the

Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

VII. Submission of Comments

Interested persons may, on or before December 14, 1998, submit to

the Dockets Management Branch (address above) written comments

regarding this rule. This comment period runs concurrently with the

comment period for the companion proposed rule. Two copies of any

comment 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 807

Confidential business information, Imports, 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 807 is amended as follows:

1. The part heading for part 807 is revised to read as follows:

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR

MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

2. The authority citation for 21 CFR part 807 continues to read as

follows:

Authority: 21 U.S.C. 331, 351, 352, 360, 360c, 360e, 360i, 360j,

371, 374.

3. Section 807.3 is amended by revising paragraphs (d)(2) and (g),

and by adding paragraph (s) to read as follows:

Sec. 807.3 Definitions.

* * * * *

(d) * * *

(2) Initial importation of devices manufactured in foreign

establishments; or

* * * * *

(g) Initial importer means any importer who furthers the marketing

of a device from a foreign manufacturer to the person who makes the

final delivery or sale of the device to the ultimate consumer or user,

but does not repackage, or otherwise change the container, wrapper, or

labeling of the device or device package.

* * * * *

(s) Wholesale distributor means any person (other than the

manufacturer or the initial importer) who distributes a device from the

original place of manufacture to the person who makes the final

delivery or sale of the device to the ultimate consumer or user.

4. Section 807.20 is amended by revising paragraph (a)(4), by

redesignating paragraph (d) as paragraph (c) and paragraph (c) as

paragraph (d), respectively, and by adding paragraph (c)(3) to read as

follows:

Sec. 807.20 Who must register and submit a device list.

(a) * * *

(4) Acts as an initial importer;

* * * * *

(c) * * *

(3) Acts as a wholesale distributor, as defined in Sec. 807.3(s),

and who does not manufacture, repackage, process, or relabel a device.

* * * * *

Sec. 807.22 [Amended]

5. Section 807.22 How and where to register establishments and list

devices is amended in paragraph (c) by removing the words

``distributor'' and ``distributors'' each time they appear

[[Page 51827]]

and by adding in their place the words ``initial importer'' and

``initial importers'', respectively.

Dated: July 15, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98-25796 Filed 9-28-98; 8:45 am]

BILLING CODE 4160-01-F