Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Notices 49247

the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

Copies of the 1997 Food Code are

available on the World Wide Web at

http://vm.cfsan.fda.gov/list.html or at

http://www.fedworld.com. The 1997

Food Code also may be purchased from

the National Technical Information

Service, U.S. Department of Commerce,

Springfield, VA 22161, in several

formats: Spiral bound, WordPerfect 6.1

files on diskette, or enhanced electronic

version on diskette or CD–Rom. The

enhanced versions include electronic

features such as hypertext links that

enable the reader to quickly locate a

specific code provision and to

simultaneously read the text of crossreferenced documents.

Dated: September 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–24956 Filed 9–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0362]

A New 510(k) Paradigm; Draft of

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 draft document entitled

‘‘A New 510(k) Paradigm—Alternate

Approaches to Demonstrating

Substantial Equivalence in Premarket

Notifications.’’ The draft 510(k)

paradigm, which is neither final nor in

effect at this time, presents two

alternative methods of demonstrating

substantial equivalence in premarket

notifications, and it is intended to

conserve FDA’s review resources while

facilitating the introduction of safe and

effective devices into interstate

commerce. The paradigm addresses the

type of data needed by the Center for

Devices and Radiological Health (CDRH)

to implement alternative procedures in

establishing substantial equivalence.

The agency requests comments on this

draft paradigm.

DATES: Submit written comments by

November 18, 1997.

ADDRESSES: Submit written requests for

single copies of the draft paradigm

entitled ‘‘A New 510(k) Paradigm—

Alternate Approaches to Demonstrating

Substantial Equivalence in Premarket

Notifications’’ 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. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the paradigm. Submit written

comments on the document to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20850.

FOR FURTHER INFORMATION CONTACT:

Robert I. Chissler, Program Operations

Staff (HFZ–404), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–1190.

SUPPLEMENTARY INFORMATION:

I. Background

The draft paradigm announced in this

document presents device

manufacturers with several optional

approaches for obtaining marketing

clearance for their Class II devices.

While the draft paradigm maintains the

traditional method of demonstrating

substantial equivalence under section

510(k) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

360(k)), it also represents 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 special

controls and consensus standards to

facilitate 510(k) review.

Under section 510(k) of the act, 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)) stipulates 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 the substantial

equivalence decision. However, FDA

has discretion in the type of information

it deems necessary to meet those

content requirements.

A. Special 510(k): Device Modification

The Safe Medical Devices Act of 1990

(the SMDA) (Pub. L. 101–629) amended

section 520(f) of the act (21 U.S.C.

360j(f)), providing FDA with the

authority to issue regulations requiring

pre-production design controls. Under

the authority provided by the SMDA,

FDA revised its current good

manufacturing practice requirements to

include pre-production design controls

that device manufacturers must follow

when initially designing devices or

when making subsequent modifications

to those designs.

Effective June 1, 1997, manufacturers

of Class II and certain Class I devices

must follow design control procedures

for their devices including device

modifications. Product modifications

that could significantly affect safety and

effectiveness are subject to 510(k)

submission requirements under 21 CFR

807 as well as design control

requirements under 21 CFR 820.30.

Because design controls are now in

effect and require the conduct of

verification and validation studies of a

type that have traditionally been

included in 510(k) submissions, FDA

believes that test results generated

under the new design control

requirements will be sufficient to serve

as a basis for certain substantial

equivalence decisions. In light of the

design control requirements, FDA

believes that it may be appropriate, in

certain circumstances, to forgo a

detailed review of the underlying data

normally required in 510(k)’s. While

FDA would not rely on the design

controls procedure requirements to

issue a determination of substantive

equivalence, it would rely on the

existence of data generated in

accordance with those procedures to

issue a substantial equivalence

determination.

Under the draft 510(k) paradigm, a

manufacturer would use the FDA

guidance document entitled, ‘‘Deciding

When to Submit A 510(k) for a Change

to an Existing Device’’ to decide if a

device modification could be

implemented without submission of a

new 510(k). If a new 510(k) is needed

for the modification and if the

modification does not affect the

intended use of the device or the basic

fundamental scientific technology of the

device, conformance with design

controls could form the basis for

clearing the application.

Special 510(k)’s will be processed by

the Office of Device Evaluation (ODE)

within 30 days of receipt by the
49248 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Notices

Document Mail Center (DMC).

Modifications which affect the intended

use or alter the basic fundamental

scientific technology of the device are

not appropriate for review under this

type of application, but rather they

should continue to be subject to routine

510(k) procedures or may be subject to

an ‘‘Abbreviated 510(k)’’ as described in

section I.B of this document.

B. Abbreviated 510(k)

The SMDA introduced the concept of

special controls as the means by which

the safety and effectiveness of Class II

devices can be ensured. Special controls

are defined by statute as those controls

that provide reasonable assurance of the

device’s safety and effectiveness.

Recently, considerable effort has been

expended to develop the concept of a

‘‘special control guidance document’’

(SCGD). Under this initiative,

reasonably foreseeable risks that are

associated with a type of Class II device

would be identified in a SCGD. For each

risk, the agency would also identify a

special control(s) such as a consensus

standard, labeling content, or

postmarket surveillance that would

address the risk.

In addition to SCGD’s that would be

developed for generic Class II devices,

CDRH is committed to recognizing

individual consensus standards. The

consensus standards could be cited in

SCGD’s, recognized in individual policy

statements, or identified as ‘‘special

controls’’ that address specific risks

associated with multiple device types.

IEC 60601 is an example of such a

consensus standard. It has broad

applicability to many electromedical

devices. FDA’s recognition of this

standard, combined with modified

review procedures, could streamline the

review of many 510(k)’s for devices

covered by the standard. Finally, by

using the accompanying particular

standards to adapt the general standard

to specific devices, the 510(k) review

process may be further expedited.

Under the draft paradigm, device

manufacturers could choose to submit

‘‘Abbreviated 510(k)’s’’ for Class II

devices when a SCGD exists or when

FDA has recognized an individual

special control such as a relevant

standard. The incentive for

manufacturers to elect to use special

controls or to declare conformance to

recognized standards would be a more

expedient review of their submissions.

II. Electronic Access

In order to receive ‘‘A New 510(k)

Paradigm—Alternate Approaches to

Demonstrating Substantial Equivalence

in Premarket Notifications’’ document

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 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 paradigm may also do so by 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. The CDRH

home page, which is updated on a

regular basis, includes: The draft

document entitled ‘‘A New 510(k)

Paradigm—Alternate Approaches to

Demonstrating Substantial Equivalence

in Premarket Notifications,’’ 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. The

paradigm will be available at http://

www.fda.gov/cdrh/ode/parad510.html.

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, submit to the

Dockets Management Branch (address

above) written comments regarding this

paradigm by November 18, 1997. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments and

requests for copies are to be identified

with the docket number found in

brackets in the heading of this

document. The paradigm and received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: September 9, 1997.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 97–24955 Filed 9–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney Diseases; Notice

of Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Institute of Diabetes and

Digestive and Kidney Diseases Special

Emphasis Panel meeting:

Name of SEP: HLA Genotyping.

Date: October 8, 1997.

Time: 3:00 p.m.

Contact Person: William Elzinga, Ph.D.,

Scientific Review Administrator, Review

Branch, NIDDK, Natcher Building, Room

6as–37A, National Institutes of Health,

Bethesda, Maryland 20892–6600, Phone:

(301) 594–8895.

Purpose/Agenda: To review and evaluate

grant applications.

This meeting will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program No. 93.847–849, Diabetes, Endocrine

and Metabolic Diseases; Digestive Diseases

and Nutrition; and Kidney Diseases, Urology

and Hematology Research, National Institutes

of Health)

Dated: September 12, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–24884 Filed 9–18–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Division of Research Grants; Notice of

Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following