Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Companion to Direct Final Rule

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; 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

certain regulations governing establishment registration and device

listing by domestic distributors. This proposed rule is a companion

document to the direct final rule published elsewhere in this issue of

the Federal Register. 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 Administration Modernization Act of 1997

(FDAMA). This companion proposed rule is being issued under FDAMA and

the act as amended.

DATES: Comments must be received on or before December 14, 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: Walter W. Morgenstern, Center for

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

Administration, 2094 Gaither Rd., Rockville, MD 20852.

SUPPLEMENTARY INFORMATION:

I. Background

This proposed rule is a companion to the direct final rule

published in the 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 adverse 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 February 11, 1999. 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 the

direct final 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 as 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 a 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

recommending a rule change in addition 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.

This action is part of FDA's continuing effort to achieve the

objectives of the President's ``Reinventing Government'' initiative,

and is intended to reduce the burden of unnecessary regulations on

medical devices without diminishing the protection of public health.

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 establishment

registration and device listing by domestic distributors:

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 distributors,'' 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.''

[[Page 51875]]

FDA is issuing this companion proposed rule to amend certain

existing regulations to conform to amendments made by FDAMA to section

510(g) of the act. For a discussion of the specific provisions of the

regulation, see the preamble to the direct final rule published

elsewhere in this issue of the Federal Register.

II. 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.

III. Analysis of Impacts

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 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 proposed rule is consistent with the regulatory philosophy and

principles identified in the Executive Order. In addition, this

proposed 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 companion proposed rule exempts certain

distributors from registration and device listing, it may permit more

small competitors to enter the marketplace. The agency 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 does not impose a mandate that results in an expenditure

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 of 1995 is not required.

IV. Paperwork Reduction Act of 1995

FDA tentatively concludes that this proposed rule contains no

collections of information. Therefore, clearance by the Office of

Management and Budget (OMB) under the Paperwork Reduction Act of 1995

(44 U.S.C. 3501-3520) is not required.

V. Submission of Comments

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

the Dockets Management Branch (address above) written comments

regarding this proposal. The comment period runs concurrently with the

comment period for the direct final 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 as 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 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, it is

proposed that 21 CFR part 807 be 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 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. 98-25797 Filed 9-28-98; 8:45 am]

BILLING CODE 4160-01-F