27988 Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 / Notices

B. PMA Supplements

In accordance with FDA regulations,

PMA supplements ordinarily are

required to be reviewed within 180 days

(21 CFR 814.39(c)).

The legislative history of section 403

of FDAMA indicates that Congress

expected FDA to publish performance

standards for those supplements

submitted for changes in product use.

Therefore, the data that follow do not

reflect FDA performance standards for

PMA supplements submitted for other

changes, e.g., labeling or manufacturing.

Historically, FDA has received

approximately 300 to 500 PMA

supplements per year. Approximately

10 percent of these supplements address

changes in the indication for use.

Performance for the PMA supplement

receipt cohort for changes in indication

received during fiscal year (FY) 1996

and FY 97 was just over 70 percent

completed within 180 days.

Tracking for PMA supplements will

continue to be accomplished using

Receipt Cohorts as the basis for program

performance. Projected performance for

the FY 98 receipt cohort for changes in

indication is expected to be 65 percent

reviewed within 180 days. This estimate

is based on making the best use of

available FY 98 resources during a time

of increasing workload attributable to

implementation of FDAMA. In FY 99,

FDA will continue reengineering the

device review process with emphasis on

these new requirements. If adequate

funding is provided, FDA expects that

performance will be back to 70 percent

in FY 99 and anticipates enhanced

performance levels in subsequent years.

III. FDAMA Section 403(c)

FDA has designated the following

individuals within CDRH and CBER to

work with sponsors to facilitate the

development and submission of data to

support supplemental applications for

approved articles in accordance with

section 403(c) of FDAMA:

Director, Office of Device Evaluation,

Center for Devices and Radiological

Health (HFZ–400), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–2022,

and

Deputy Director, Medical Center for

Biologics Evaluation and Research

(HFM–1), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

3028.

IV. Comments

Interested persons may, on or before

August 19, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this notice.

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. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

Dated: May 18, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–13721 Filed 5–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0333]

Guidance for Industry, Supplements to

Approved Applications for Class III

Medical Devices: Use of Published

Literature, Use of Previously

Submitted Materials, and Priority

Review; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the guidance entitled,

‘‘Guidance for Industry, Supplements to

Approved Applications for Class III

Medical Devices: Use of Published

Literature, Use of Previously Submitted

Materials, and Priority Review.’’ The

FDA Modernization Act of 1997

(FDAMA) requires the agency to issue

final guidance to clarify circumstances

in which published matter may be the

basis for approval of a supplemental

application, specify data requirements

that will avoid duplication of previously

submitted data by recognizing the

availability of data previously submitted

in support of an original application and

define supplemental applications that

are eligible for priority review.

DATES: Written comments concerning

this guidance may be submitted at

anytime.

ADDRESSES: Submit written requests for

single copies on a 3.5’’ diskette of the

guidance document entitled, ‘‘Guidance

for Industry, Supplements to Approved

Applications for Class III Medical

Devices: Use of Published Literature,

Use of Previously Submitted Materials,

and Priority Review’’ to the Division of

Small Manufacturers Assistance (HFZ–

220), Center for Devices and

Radiological, 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.

Submit written comments on

‘‘Guidance for Industry, Supplements to

Approved Applications for Class III

Medical Devices: Use of Published

Literature, Use of Previously Submitted

Materials, and Priority Review’’ to the

contact persons listed below. See the

SUPPLEMENTARY INFORMATION

section for information on electronic

access to the guidance.

FOR FURTHER INFORMATION CONTACT:

Kathy M. Poneleit, Center for Devices

and Radiological Health (HFZ–402),

Food and Drug Administration,

9200 Corporate Blvd., Rockville,

MD 20850, 301–594–2186; or

Jerome A. Donlon, Center for

Biologics Evaluation and Research,

1401 Rockville Pike (HFM–200),

Rockville, MD 20852–1448, 301–

827–3028.

SUPPLEMENTARY INFORMATION:

I. Background

Section 403(b) of FDAMA (Pub.

L.105–115) provides that not later than

180 days after the date of enactment, the

Secretary of the Department of Health

and Human Services (FDA by

delegation) shall issue final guidances to

clarify the requirements for, and

facilitate the submission of data to

support, the approval of supplemental

applications for approved articles under

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 301 et seq.) or

section 351 of the Public Health Service

Act (42 U.S.C. 262). The guidances

shall:

(1) Clarify circumstances in which

published matter may be the basis for

approval of a supplemental application;

(2) Specify data requirements that will

avoid duplication of previously

submitted data by recognizing the

availability of data previously submitted

in support of an original application;

and

(3) Define supplemental applications

that are eligible for priority review.

Section 403(b) of FDAMA is

applicable to multiple centers within

FDA. Availability of the draft guidance

prepared by the Center for Drug

Evaluation and Research (CDER) and the

Center for Biologics Evaluation and

Research (CBER) (CDER/CBER draft

guidance) was announced in the

Federal Register of March 21, 1997 (62

FR 13650). The CDER/CBER draft

guidance describes the use of literature

and the types of study design that may

support supplemental effectiveness

claims for approved drug and biological

products. CDRH issued draft guidance
Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 / Notices 27989

on March 20, 1998, that set forth its

perspective on the applicability of the

CDER/CBER draft guidance to medical

devices.

The agency received two comments

on the draft guidance. Both comments

encouraged the agency to issue two

separate guidance documents, one for

devices and one for drugs and biologics,

rather than a single guidance document.

Also, both comments requested devicespecific examples in the guidance

document. One comment requested

additional guidance on other provisions

of FDAMA.

Although CDRH initially had

expected the final guidance issued in

accordance with 403(b) of the act to be

a single agency document that

addressed devices, drugs and biologics,

both CDRH and CBER have decided, in

the interest of clarity and consistent

with comments received on the draft

guidance, to issue a separate guidance

document for medical devices. This

final guidance for medical devices

builds upon the foundation developed

in the CDER/CBER draft guidance

regarding the use of published

literature, draws upon the existing

premarket approval application (PMA)

regulation, and refers to earlier guidance

documents developed by CDRH that

describe efforts to avoid duplication of

previously submitted data and that

define supplemental applications that

are eligible for priority review. In this

final guidance, device specific examples

have replaced the drug examples

presented in the CDER/CBER draft

guidance.

This guidance has been revised to

account for all class III products

approved as PMA’s, including

humanitarian device exemption (HDE)

products and product development

protocols (PDP’s). A Class III device for

which a PDP has been declared

completed by FDA is considered to have

an approved PMA § 814.19 (21 CFR

814.19). Supplements to PDPs,

therefore, will be treated as PMA

supplements for purposes of this

guidance. This guidance also provides

examples of how the use of published

literature may be used in support of a

PMA, PDP, or HDE supplement.

Published literature would most

frequently be used to support

supplements for new indications for use

of an approved device. In accordance

with § 814.110, an applicant seeking

approval for a new indication for use for

an approved humanitarian use device

must submit an original HDE. Therefore,

this guidance would apply to HDE

supplements only in unusual

circumstances. The agency intends to

issue additional guidance documents on

other provisions of FDAMA and will

solicit public comment on those

guidances in accordance with FDA’s

Good Guidance Practices.

II. Significance of Guidance

This guidance document represents

the agency’s current thinking on

‘‘Guidance for Industry, Supplements to

Approved Applications for Class III

Medical Devices: Use of Published

Literature, Use of Previously Submitted

Materials, and Priority Review.’’ Both

the Center for Devices and Radiological

Health (CDRH) and the Center for

Biologics Evaluation and Research

(CBER) have responsibilities for the

regulation of medical devices. This

document applies to medical devices

regulated by either CDRH or CBER and

reflects the current thinking of both

centers on the subject of this guidance.

This document does not apply to

medical devices licensed by CBER. This

document is being issued as final

guidance. 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 guidance document is

issued as a Level 1 guidance consistent

with GGPs. Written comments may be

submitted at any time.

III. Electronic Access

In order to receive ‘‘Guidance for

Industry, Supplements to Approved

Applications for Class III Medical

Devices: Use of Published Literature,

Use of Previously Submitted Materials,

and Priority Review’’ 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 (380) 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 World Wide

Web 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 ‘‘Guidance for

Industry, Supplements to Approved

Applications for Class III Medical

Devices: Use of Published Literature,

Use of Previously Submitted Materials,

and Priority Review,’’ 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. This

guidance is also available from CBER on

the World Wide Web at http://

www.fda.gov/cber/guidelines.htm.

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, at any time,

submit to the contact person (address

above) written comments regarding this

final guidance. Such comments will be

considered when determining whether

to amend the current 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 may

be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: May 18, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–13720 Filed 5–20–98; 8:45 am]

BILLING CODE 4160–01–F