Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices 39099

regarding the exemption of the device

that was the subject of the notice. If FDA

fails to respond to a petition under this

section within 180 days of receiving it,

the petition shall be deemed granted.

II. Criteria for Exemption

There are a number of factors FDA

may consider to determine whether a

510(k) is necessary to provide

reasonable assurance of the safety and

effectiveness of a class II device. These

factors are discussed in the guidance the

agency issued on February 19, 1998,

entitled ‘‘Procedures for Class II Device

Exemptions from Premarket

Notification, Guidance for Industry and

CDRH Staff.’’ That guidance can be

obtained through the World Wide Web

on the CDRH Home Page at ‘‘http://

www.fda.gov/cdrh’’ or by facsimile

through CDRH Facts-on-Demand at 1–

800–899–0381 or 301–827–0111.

Specify ‘‘159’’ when prompted for the

document shelf number.

III. List of Petitions

FDA has received the following

petitions requesting an exemption from

premarket notification for class II

devices:

1. Sandhill Scientific Inc., 21 CFR

876.1725 Gastrointestinal motility

monitoring system.

2. Welch Allyn, Inc., 21 CFR 886.1570

Ophthalmoscope.

3. Computerized Medical Systems,

Inc., 21 CFR 892.5840 Radiation therapy

simulation system, exemption requested

only for Radiation Oncologist Data Entry

Workstation.

4. Chemicon International Inc., 21

CFR 866.3175 Cytomegalovirus

serological reagents, and 21 CFR

866.3900 Varicella-zoster virus

serological reagents.

IV. Comments

Interested persons may, on or before

August 20, 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. The petitions and received

comments may be seen in the office

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

Monday through Friday.

Dated: July 10, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–19316 Filed 7–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0437]

New Model Medical Device

Development Process; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration FDA is announcing the

availability of a document entitled

‘‘New Model Medical Device

Development Process.’’ In this

document, FDA outlines a new model

for the investigational device exemption

(IDE) and premarket approval

application (PMA) development and

review process. FDA is issuing this

document as part of its commitment to

improve the IDE and PMA development

and review process.

DATES: Written comments concerning

this document must be received by

October 19, 1998.

ADDRESSES: See the SUPPLEMENTARY

INFORMATION section for information on

electronic access to the document.

Written comments concerning this

document must be submitted to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Comments should be

identified with the docket number

found in brackets in the heading of this

document. Submit written requests for

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

Model Medical Device Development

Process’’ to the Division of Small

Manufacturers Assistance, Center for

Devices and Radiological Health (HFZ–

220), 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.

FOR FURTHER INFORMATION CONTACT:

Robert R. Gatling, Center for Devices

and Radiological Health (HFZ–470),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1220.

SUPPLEMENTARY INFORMATION:

I. Background

Despite a marked improvement in

device approval times, FDA’s Center for

Devices and Radiological Health (CDRH)

is committed to substantial

improvement of the IDE application and

PMA development and review process.

Often FDA’s involvement with the

product has been greatest at the end of

the process—during review of the PMA.

The lack of early and effective FDA and

sponsor interaction too often results in

a PMA with significant flaws requiring

repair, including development of

additional data, and multiple cycles of

PMA review. These cycles can be costly

and time consuming both for the

medical device industry and FDA and

can delay marketing of new devices.

As part of its reengineering process,

CDRH is proposing a new model for the

development and review of such class

III medical devices that includes three

tracks: (1) ‘‘Expedited’’ review for

devices which offer significant

advantages over current therapy; (2)

‘‘standard’’ review for most devices; and

(3) ‘‘streamlined’’ review for devices

which are very well understood by both

the sponsor and FDA.

The new model also encourages

interaction between the agency and the

applicant, including early agreement on

the overall development plan, and offers

modular submission and review

building the application and

administrative file over time.

The guidance document outlines why

FDA believes that the model will lead

to ‘‘fast, fair, and smart’’ decisions that

bring safe and effective devices to

market as early as possible.

This guidance document represents

the agency’s current thinking on

expediting the IDE/PMA process. 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. FDA is issuing this

as a Level 1 guidance document. Public

comment prior to implementation is not

required because the guidance is

presenting a less burdensome policy

that is consistent with the public health.

II. Electronic Access

In order to receive ‘‘New Model

Medical Device Development Process’’

via your fax machine, call the CDRH

Facts-On-Demand (FOD) system at 1–

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 (1101)

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
39100 Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices

with access to the Web. Updated on a

regular basis, the CDRH home page

includes ‘‘New Medical Device

Development Process’’ 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

1–800–222–0185 (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, on or before

October 19, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

document. 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

document and received comments may

be seen in the Dockets Management

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

Monday through Friday.

Dated: July 10, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–19318 Filed 7–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0133]

Revised Guidance for Industry on

Implementation of Section 126 of the

Food and Drug Administration

Modernization Act of 1997—

Elimination of Certain Labeling

Requirements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a revised guidance for

industry entitled ‘‘Implementation of

Section 126 of the Food and Drug

Administration Modernization Act of

1997— Elimination of Certain Labeling

Requirements.’’ Section 126 of the Food

and Drug Administration Modernization

Act of 1997 (Modernization Act)

amends the Federal Food, Drug, and

Cosmetic Act (the act) to require, at a

minimum, that prior to dispensing, the

label of prescription products contain

the symbol ‘‘Rx only’’ instead of the

‘‘Caution: Federal law prohibits

dispensing without prescription’’

statement. In addition, the requirement

that the labels of certain habit-forming

drugs bear the statement ‘‘Warning-May

be habit forming’’ has been repealed.

The revised guidance changes the

implementation schedule provided in

the original guidance dated February

1998, and answers certain questions

concerning implementation of these

amendments.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Copies of this guidance for

industry can be obtained on the Internet

at http://www.fda.gov/cder/guidance/

index.htm or http://www.fda.gov/cber/

guidelines.htm. Submit written requests

for single copies of this guidance to the

Drug Information Branch (HFD–210),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857 or to the Office of

Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Jerry Phillips, Center for Drug

Evaluation and Research (HFD–

610), Food and Drug

Administration, Office of Generic

Drugs, 7500 Standish Pl., Rockville,

MD 20855, 301–827–5846, or

Robert A. Yetter, Center for Biologics

Evaluation and Research (HFM–10),

Food and Drug Administration,

1401 Rockville Pike, Rockville, MD

20852–1448, 301–827–0373.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a revised

guidance for industry entitled

‘‘Implementation of Section 126 of the

Food and Drug Administration

Modernization Act of 1997—

Elimination of Certain Labeling

Requirements.’’ Section 126 of Title I of

the Food and Drug Administration

Modernization Act of 1997 (Pub. L. 105–

115), signed into law by President

Clinton on November 21, 1997, amends

section 503(b)(4) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 353(b)(4)) to require, at a

minimum, that prior to dispensing, the

label of prescription products contain

the symbol ‘‘Rx only’’ instead of the

‘‘Caution: Federal law prohibits

dispensing without prescription’’

statement. In addition, section 502(d) of

the act (21 U.S.C. 352(d)), that required

the labels of certain habit-forming drugs

to bear the statement ‘‘Warning–May be

habit forming’’ is repealed. The

amendments to section 503(b)(4) and

the repeal of section 502(d) of the act

became effective February 19, 1998.

FDA published a notice in the Federal

Register of March 13, 1998, announcing

the availability of the original guidance

(63 FR 12473) and soliciting comments.

Three comments on the guidance were

submitted to the docket. In response to

the comments, and to questions that

were asked concerning the

implementation of section 126 of the

Modernization Act, FDA is issuing a

revised guidance.

The revised guidance: (1) Describes

the new prescription drug labeling

requirements of the act as amended by

the Modernization Act, (2) changes the

implementation schedule previously

described in the February 1998

guidance, and (3) answers certain

frequently asked questions about the

provision. The revised guidance advises

that FDA does not intend to object if a

sponsor of a currently approved product

implements section 126 of the

Modernization Act at the time of the

next revision of its labels, or by

February 19, 2003, whichever comes

first, and reports these minor changes in

the next annual report. For pending