Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices 36247

nor an environmental impact statement

is required.

Dated: June 17, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–17547 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0195]

Agreement on Mutual Recognition

Between the United States of America

and the European Community; Third

Party Review Program Under the

Sectoral Annex on Medical Devices;

Conformity Assessment Bodies

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is identifying the

process for designating Conformity

Assessment Bodies (CAB’s) under the

Sectoral Annex on Medical Devices to

the Agreement on Mutual Recognition

Between the United States of America

and the European Community (MRA).

The MRA was signed in London on May

18, 1998, but it has not entered into

force. FDA has published a proposed

rule on the parts of the MRA affecting

FDA-regulated products. This notice

announces the process for CAB’s to

become eligible for designation under

the Sectoral Annex on Medical Devices

(Medical Devices Annex). The

availability of the draft guidance

detailing the requirements for

performing evaluations, training for

CAB’s, and content of evaluation reports

by FDA is announced elsewhere in this

issue of the Federal Register. Also

announced elsewhere in this issue of

the Federal Register is an emergency

processing request for Office of

Management and Budget review of the

information collection provisions of this

notice.

FOR FURTHER INFORMATION CONTACT:

Regarding the U.S./European

Community MRA: John F. Stigi,

Director, Division of Small

Manufacturers Assistance (HFZ–

220), Center for Devices and

Radiological Health, Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, 301–443–

6597, or FAX: 301–443–8818.

Regarding the process for being

recognized to assess U.S. CAB’s or

for naming a recognized accreditor:

Robert L. Gladhill, Conformity

Assessment Systems Evaluation,

National Institute of Standards and

Technology, NN, 282 Gaithersburg,

MD 20899, 301–975–4273, or FAX:

301–963–2871.

SUPPLEMENTARY INFORMATION:

I. Background

On June 20, 1997, the United States

and the European Community (EC)

completed negotiation of the MRA that

covered a variety of product sectors,

including telecommunication

equipment, recreational craft,

pharmaceuticals, and medical devices.

The Medical Devices Annex applies

only to medical devices manufactured

for export to the United States or EC.

The EC consists of the following

member States: Austria, Belgium,

Denmark, Finland, France, Germany,

Greece, Ireland, Italy, Luxembourg, The

Netherlands, Portugal, Spain, Sweden,

and the United Kingdom. FDA issued a

proposed rule on April 10, 1998 (63 FR

17744), to add a new section to its

regulations setting out requirements

through which FDA may normally

endorse certain reports of conformity

assessments. The Medical Device Annex

applies to reports of quality system

evaluations of all medical devices and

premarket evaluations of selected

medical devices provided by designated

conformity assessment bodies.

Assuming the MRA enters into force

and a final rule becomes effective, a 3-

year transition period will start during

which time both sides will engage in

confidence building activities. After the

3-year transition period and the

confidence building activities are

successfully completed, the operational

period will begin.

The MRA consists of a framework

agreement and individual sectoral

annexes (i.e., those product sectors

covered by the MRA). The framework

agreement covers the general aspects of

the implementation of the agreement as

well as the requirements governing the

CAB’s, such as designation, listing,

suspension, and withdrawal.

Within the framework agreement

there is a provision that FDA and EC

Designating Authorities review the

Medical Devices Annex. It is anticipated

that aspects of the Medical Devices

Annex will be modified by agreement of

FDA and EC Designating Authority as

laws and policies change. This

provision was included because of

FDA’s concern during the negotiations

that there could be a change in the

status of the FDA Third Party Review

Pilot Program for medical devices that

would change the nature of the

agreement.

Under the MRA, an EC CAB could

conduct quality system evaluations for

all classes of devices and premarket

510(k) evaluations for selected devices

based on FDA requirements. Similarly,

a U.S. CAB could conduct quality

system evaluations for all classes of

devices and product type examinations

and verifications for selected devices

based on EC requirements. In addition,

an alert system would be set up during

the transition period and maintained

thereafter by which FDA and regulatory

authorities will notify each other when

there is an immediate danger to public

health. As part of that system, FDA and

EC will notify each other of any

confirmed problem reports, corrective

actions, or recalls.

The MRA may: (1) Be an important

means of facilitating movement of

medical devices important to human

health between the United States and

EC, (2) enhance public health by

allowing better use of scarce FDA

resources, (3) enhance harmonization of

U.S. and EC regulatory systems, and (4)

permit FDA to better utilize its

regulatory resources to focus on

manufacturers located in other

countries.

Under the MRA, both the United

States and the EC may eventually be

able to save resources by utilizing

evaluations of manufacturers conducted

by the other party, thereby saving

overseas travel time and expense.

However, CAB’s will be required to

participate in rigorous joint activities in

order to demonstrate proficiency in

conducting FDA and EC evaluations.

Based on demonstrated proficiency

during a 3-year transition period, both

FDA and EC are expected to ‘‘normally

endorse’’ evaluations conducted by the

other party’s CAB’s, while reserving the

final decision making to themselves and

reserving the right to conduct their own

evaluations should significant

deficiencies be found in any reports.

II. Third Party Review Program

The Medical Devices Annex identifies

legislation, regulations, and related

procedures under which: (1) Products

are regulated as medical devices by each

party (i.e., FDA and the EC); (2) CAB’s

are designated and confirmed; and (3)

evaluation reports are prepared.

Assuming the MRA enters into force

and a final rule becomes effective, FDA

will be the Designating Authority for

U.S. CAB’s and the EC Regulatory

Authorities will be the Designating

Authority for EC CAB’s. FDA intends to

use the National Voluntary Conformity

Assessment System Evaluation
36248 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices

(NVCASE) administered by the National

Institute of Standards and Technology

(NIST) of the U.S. Department of

Commerce to recognize one or more

accreditation bodies that, in turn, will

assess potential U.S. CAB’s seeking to

be designated under the MRA to assess

medical devices produced for the EC

market. FDA will consider the

recommendations made by the

recognized accreditation bodies from

June 1, 1998, until October 1, 1998,

review the list of recommended CAB’s,

and then designate U.S. CAB’s that meet

criteria for technical competence set

forth in the Medical Devices Annex,

assuming the MRA enters into force and

a final rule on the MRA becomes

effective. FDA intends to conduct

training for EC CAB’s from October 14

to 23, 1998.

Assessment of prospective U.S. CAB’s

for purposes of conducting quality

system evaluations and product typeexamination and verifications will be

conducted under the NVCASE program

under the procedures set forth in 15

CFR part 286. Prospective U.S. CAB’s

and accreditation bodies should contact

NIST for additional information.

Applications for designation should

include sufficient information to

address the qualifications for CAB’s set

forth in Article 1, Paragraph 1 of the

Medical Devices Annex of the MRA. At

a minimum, qualified U.S. CAB’s

should have knowledge of:

(1) Council Directive 90/385/EEC of

June 20, 1990, on active implantable

medical devices OJ No. L 189, 20.7.1990

(p. 17). Conformity assessment

procedures: Annex 2 (with the

exception of section 4), Annex 4, and

Annex 5.

(2) Council Directive 93/42/EEC of

June 14, 1993, on medical devices OJ

No. L 169, 12.7.1993 (p. 1). Conformity

assessment procedures: Annex 2 (with

the exception of section 4), Annex 3,

Annex 4, Annex 5, and Annex 6.

Assuming the MRA enters into force

and a final rule becomes effective,

designation of EC CAB’s for the purpose

of conducting quality system

evaluations and premarket 510(k)

evaluations will be conducted in accord

with the Medical Devices Annex. At a

minimum, qualified EC CAB’s should

have knowledge of:

(1) The Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321 et seq.),

(2) The Public Health Service Act (42

U.S.C. 201 et seq.),

(3) Regulations of the United States

Food and Drug Administration (21 CFR

parts 800 to 1299); and

(4) The Federal Register document on

the pilot program for third-party review

of selected premarket notifications for

medical devices that was published on

April 3, 1996 (61 FR 14789 at 14796).

Prospective EC CAB’s should contact

their European Regulatory Authority,

not FDA, for further information.

Following designation, the EC CAB’s

can expect to be monitored through

FDA surveillance audits at intervals

determined by the agency.

III. Environmental Impact

The agency has determined under 21

CFR 25.34(h) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

IV. Analysis of Impacts

FDA has examined the impacts of the

U.S./EC MRA third party review

program under Executive Order 12866

and the Regulatory Flexibility Act (Pub.

L. 96–354), as amended by subtitle D of

the Small Business Regulatory Fairness

Act of 1996 (Pub. L. 104–121), and the

Unfunded Mandates Reform Act of 1995

(Pub. L. 104–4). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this voluntary program is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

program is not a significant regulatory

action as defined by the Executive Order

and so is not subject to review under the

Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. This regulation provides

alternative review options for certain

types of submissions. This is a

voluntary program which imposes no

additional requirements on regulated

industry. Accordingly, the agency

certifies that the program, if

implemented, would not have a

significant economic impact on small

entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

Dated: June 24, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–17597 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Circulatory System Devices Panel of

the Medical Devices Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Circulatory

System Devices Panel of the Medical

Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 21 and 22, 1998, 8 a.m. to

5 p.m.

Location: Holiday Inn, Ballroom, Two

Montgomery Village Ave., Gaithersburg,

MD.

Contact Person: John E. Stuhlmuller,

Center for Devices and Radiological

Health (HFZ–450), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–443–8243,

ext. 157, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 12625. Please call the

Information Line for up-to-date

information on this meeting.

Agenda: On July 21, 1998, the

committee will discuss, make

recommendations, and vote on a

premarket approval application (PMA)

for a cardiac ablation device for

ventricular tachycardia. On July 22,

1998, the committee is being asked to

provide input to the agency regarding

the design of clinical trials to support

PMA’s for cardiac ablation devices

intended to treat atrial fibrillation and

atrial flutter. Of particular concern are

the following issues: (1) What are the

appropriate controls to be used in such

trials? (2) What are the appropriate

safety and efficacy measures? and (3)

When should assessments of these

measures be made?

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 10, 1998. Oral

presentations from the public will be

scheduled between approximately 8

a.m. and 8:30 a.m. Near the end of