Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 / Notices 25865

Federal Register in accordance with 21

CFR 25.40(c).

Dated: April 24, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–12313 Filed 5–8–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0362]

The New 510(k) Paradigm; Alternate

Approaches to Demonstrating

Substantial Equivalence in Premarket

Notifications; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled ‘‘The

New 510(k) Paradigm-Alternate

Approaches to Demonstrating

Substantial Equivalence in Premarket

Notifications.’’ The New 510(k)

Paradigm presents two alternative

methods, in addition to the traditional

method, of demonstrating substantial

equivalence in premarket notifications

and is intended to conserve FDA’s

review resources while facilitating the

introduction of safe and effective

devices into interstate commerce. The

New 510(k) Paradigm addresses the type

of information needed in premarket

notification submissions, by the Center

for Devices and Radiological Health

(CDRH), to render substantial

equivalence determinations.

DATES: May 11, 1998.

ADDRESSES: Submit written requests for

single copies on a 3.5’’ diskette of ‘‘The

New 510(k) Paradigm-Alternate

Approaches to Demonstrating

Substantial Equivalence in Premarket

Notifications,’’ to the Division of Small

Manufacturers Assistance (DSMA),

Center for Devices and Radiological

Health (HFZ–220), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818.

Comments should be identified with the

docket number found in brackets in the

heading of this document. See the

SUPPLEMENTARY INFORMATION

section for information on electronic

access to the guidance.

FOR FURTHER INFORMATION CONTACT:

Philip J. Phillips, Center for Devices and

Radiological Health (HFZ–400), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2022.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 510(k) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360(k)), a person who intends

to introduce a device into commercial

distribution is required to submit a

premarket notification, or 510(k), to

FDA at least 90 days before commercial

distribution is to begin. Section 513(i) of

the act (21 U.S.C. 360c(i)) states that

FDA may issue an order of substantial

equivalence, only upon making a

determination that the device to be

introduced into commercial distribution

is as safe and effective as a legally

marketed device. Under 21 CFR 807.87,

FDA has codified the content

requirements for premarket notifications

to be submitted by device manufacturers

in support of a substantial equivalence

decision. FDA has, however, discretion

in the type of information it deems

necessary to meet those content

requirements.

While the Paradigm maintains the

traditional method of demonstrating

substantial equivalence under section

510(k) of the act, it also presents two

alternatives. The first alternative, the

‘‘Special 510(k): Device Modification,’’

utilizes certain aspects of the Quality

System regulation, while the second

alternative, the ‘‘Abbreviated 510(k),’’

relies on the use of FDA guidance

documents, special controls and FDA

recognized consensus standards to

facilitate 510(k) review.

In the Federal Register of September

19, 1997 (62 FR 49247), FDA published

a notice of availability of a draft of this

guidance document on the Paradigm.

FDA received 13 comments on the draft.

FDA reviewed these comments and has

made revisions to the guidance as

appropriate.

This guidance document represents

the agency’s current thinking on the

510(k) Paradigm. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

applicable statute, regulations, or both.

II. Electronic Access

In order to receive ‘‘A New 510(k)

Paradigm-Alternate Approaches to

Demonstrating Substantial Equivalence

in Premarket Notifications,’’ via your fax

machine, call the CDRH Facts-OnDemand (FOD) system at 800–899–0381

or 301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at second

voice prompt press 2, and then enter the

document number 905 followed by the

pound sign (#). Then follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the guidance may also do so using the

World Wide Web (WWW). CDRH

maintains an entry on the WWW for

easy access to information including

text, graphics, and files that may be

downloaded to a personal computer

with access to the Web. Updated on a

regular basis, the CDRH home page

includes: Device safety alerts, Federal

Register reprints, information on

premarket submissions (including lists

of approved applications and

manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh.

A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

800–222–0185 (terminal settings are 8/

1/N). Once the modem answers, press

Enter several times and then select

menu choice 1:FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS Topics Page, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select Medical

Devices and Radiological Health. From

there select CENTER FOR DEVICES

AND RADIOLOGICAL HEALTH for

general information, or arrow down for

specific topics.

III. Comments

Interested persons may, at any time,

submit to the contact person named

above written comments regarding this

guidance document. Comments will be

considered in determining whether to

revise or revoke the guidance.

Dated: May 1, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–12311 Filed 5–8–98; 8:45 am]

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