28392 Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0298]

Guidance for Industry on General/

Specific Intended Use; Draft;

Availability

AGENCY: Food and Drug

Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

entitled ‘‘Guidance for Industry on

General/Specific Intended Use.’’ This

draft guidance is not final or in effect at

this time. The purpose of this draft

guidance is to help medical device

manufacturers understand the

principles used by FDA to determine

whether the addition of a specific

indication for use to a medical device

cleared for marketing with a general

indication for use could trigger the need

for a premarket approval application

(PMA). The draft guidance is intended

to help manufacturers answer the

following questions: Under what

circumstances is a device with a new,

specific indication for use likely to be

found to be substantially equivalent to

a device legally marketed for a general

indication for use? Conversely, when

does a specific indication for use

become a new intended use that

requires submission of a PMA to

establish the safety and effectiveness of

the device?

DATES: Written comments concerning

this draft guidance must be submitted

by June 22, 1998.

ADDRESSES: Submit written requests for

single copies on a 3.5’’ diskette of the

draft guidance entitled ‘‘Guidance for

Industry on General/Specific Intended

Use’’ to the Division of Small

Manufacturers Assistance (HFZ–220),

Center for Devices and Radiological

Health, Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850.

Send two self-addressed adhesive labels

to assist that office in processing your

request, or fax your request to 301–443–

8818. Submit written comments

concerning this draft guidance to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Comments should

be identified with the docket number

found in brackets in the heading of this

document. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:

Daniel G. Schultz, Center for Devices

and Radiological Health (HFZ–470),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–5072.

SUPPLEMENTARY INFORMATION:

I. Background

Congress indicated that FDA should

provide additional guidance on the

approach that the agency takes when

evaluating whether a new indication for

use, which appears to fall within the

scope of the intended use of a legally

marketed predicate device, is a new

intended use that would require a PMA.

This guidance is issued in accordance

with new section 513(i)(1)(F) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360c(i)(1)(F)), which was

added by section 206 of the Food and

Drug Administration Modernization Act

of 1997 (Pub. L. 105–115).

II. Significance of Guidance

This draft guidance represents the

agency’s current thinking on general/

specific intended use. 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.

The agency has adopted good

guidance practices (GGP’s), which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (62 FR 8961, February 27,

1997). This draft guidance is issued as

a Level 1 guidance consistent with

GGP’s.

III. Electronic Access

In order to receive copies of the draft

guidance entitled ‘‘Guidance for

Industry on General/Specific Intended

Use’’ via your fax machine, call the

CDRH Facts-On-Demand (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 the second voice prompt press

2, and then enter the document number

499 followed by the pound sign (#).

Then follow the remaining voice

prompts to complete your request.

Persons interested in obtaining a copy

of the draft 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 the draft guidance entitled

‘‘Guidance for Industry on General/

Specific Intended Use,’’ 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.

IV. Comments

Interested persons may, on or before

June 22, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this draft

guidance. 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 brackets in the

heading of this document. The guidance

document and received comments may

be seen in the office above between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: May 12, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–13798 Filed 5–21–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0312]

Draft Guidance for Staff, Industry, and

Third Parties: Implementation of Third

Party Programs Under the FDA

Modernization Act of 1997; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the