FDA Modernization Act of 1997: Modifications to the List of Recognized Standards; Availability; Withdrawal of Draft Guidance ``Use of IEC 60601 Standards; Medical Electrical Equipment''

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D-0530]

FDA Modernization Act of 1997: Modifications to the List of

Recognized Standards; Availability; Withdrawal of Draft Guidance ``Use

of IEC 60601 Standards; Medical Electrical Equipment''

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

publication of the modifications to the list of standards that will be

recognized for use in the premarket review process and withdrawing its

draft guidance entitled ``Use of IEC 60601 Standards; Medical

Electrical Equipment.'' This will assist manufacturers who elect to

declare conformity with consensus standards to meet all or part of

medical device review requirements.

DATES: This recognition of standards is effective on November 16, 1998;

however, written comments concerning this notice may be submitted at

any time.

ADDRESSES: Submit written requests for single copies of ``Modifications

to the List of Recognized Standards'' to the Division of Small

Manufacturers Assistance (DSMA), 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 requests, or fax your request to 301-

443-8818. Written comments concerning this document must be submitted

to the contact person listed below. 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

guidance. This document may also be accessed via the Internet at FDA's

web site ``http://www.fda.gov/cdrh''.

FOR FURTHER INFORMATION CONTACT: To comment on this document and/or to

recommend additional standards for recognition: James J. McCue, Jr.,

Center for Devices and Radiological Health (HFZ-101), Food and Drug

Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-

4766, ext. 137.

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act

of 1997 (FDAMA) (Pub. L. 105-115, 111 Stat. 2296 (1997)) amends section

514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.

360d), allowing the agency to recognize consensus standards established

by international and national standards development organizations that

may be used to satisfy identified portions of device premarket review

submissions or other requirements. In a previous notice published in

the Federal Register of February 25, 1998 (63 FR 9561), FDA announced

the availability of a guidance document entitled ``Recognition and Use

of Consensus Standards,'' which describes how FDA will implement that

part of FDAMA, and provided the initial list of recognized standards

(the February 1998 notice). This document announces modifications to

the list of consensus standards to be recognized for use by FDA.

II. Recognition and Use of IEC 60601 Standards

In the Federal Register of January 13, 1998 (63 FR 1974), FDA

published a notice that announced the availability of a draft guidance

entitled ``Use of IEC 60601 Standards; Medical Electrical Equipment''

(the January 1998 notice). The purpose of the draft was to provide

guidance to the Office of Device Evaluation reviewers on the use of the

International Electrotechnical Commission (IEC) 60601 series of

standards, including declarations of conformity to the standards,

during the evaluation of premarket submissions for electrical medical

devices.

FDA has decided not to finalize this draft guidance document.

Instead, recognition of the IEC 60601 standards will occur by listing

in this publication ``Modifications to the List of Recognized

Standards.'' There appears to be little, if any, benefit to finalizing

guidance on FDA's use of IEC 60601 standards in a separate document

from the general recognition of consensus standards under FDAMA,

announced in the February 1998 notice, especially as there is a fair

amount of overlap between the two documents.

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In response to the January 1998 notice, FDA received one comment on

the draft guidance. The comment contained some specific recommendations

concerning IEC 60601-1-2 on Electromagnetic Compatibility (EMC). These

recommendations were considered in developing the supplementary

information sheet for this standard that is maintained on the FDA Web

site. The comment also included recommended changes to the draft

guidance which are now not necessary because the draft guidance will

not be finalized. However, most of the recommended changes were

accommodated in the guidance ``Recognition and Use of Consensus

Standards'' announced in the February 1998 notice. Finally, the comment

recommended an additional standard (newly published) in the 60601

series for recognition. This standard will be treated as an official

recommendation according to the ``Guidance on the Recognition and Use

of Consensus Standards'' and will be considered in due course.

In the February 1998 notice, one of the recognized standards was

IEC 60601-1. This ``Modifications to the List of Recognized Standards''

includes the IEC 60601-1 standard again because the associated

supplementary information sheet has been modified, partly to include

reference to the two amendments to IEC 60601-1 which are being

recognized by this modified list. Also, some of the IEC 60601 part 2

standards referenced in the January 1998 notice do not appear in this

modified list. This is because there was not sufficient time to

complete the detailed evaluations and prepare the supplementary

information sheets for these standards. They should appear in future

Federal Register notices of recognized standards.

III. List of Recognized Standards

Modifications to the list of consensus standards to be recognized

for use in premarket review and to meet other requirements are

presented at the end of this document. This list is also maintained on

the FDA Web site ``http://www.fda.gov/cdrh''. Also posted on the Web

site are supplementary information sheets for each recognized standard.

These information sheets list the address(es) where the standard can be

obtained, information on any limitations on the application of the

standard in medical device review or in satisfying other regulatory

requirements, and a list of devices for which declarations of

conformity with the recognized standard will be routinely accepted by

agency reviewers. In addition to these documents, the web site contains

answers to frequently asked questions regarding the use of recognized

standards.

In the February 1998 notice, one of the recognized standards, under

the OB-GYN/GASTROENTEROLOGY heading, was ASTM D3492-96. This

publication ``Modifications to the List of Recognized Standards''

removes the February 25, 1998, recognition and adds recognition of ASTM

3492-96 in part. The associated supplementary information sheet

excludes from recognition the standards quality inspection for air

burst properties and water leakage which are different than the FDA

requirements.

IV. Recommendation of Standards for Recognition by FDA

Modifications to the list of recognized consensus standards related

to medical devices will be announced in the Federal Register at least

once a year, or more often if necessary.

Any person may recommend consensus standards as candidates for

recognition under the new paragraph of section 514 of the act by

submitting such recommendations, with justification, to DSMA (address

above). To be properly considered, such recommendations should contain,

at a minimum, the following information: (1) Title of standard, (2) any

reference number and date, (3) name and address of the nationally or

internationally recognized standards development organization, (4) a

proposed list of devices for which a declaration of conformity should

routinely apply, and (5) a brief identification of the testing or

performance or other characteristics of the device(s) that would be

addressed by a declaration of conformity.

V. Electronic Access

In order to receive the guidance document ``Recognition and Use of

Consensus Standards,'' 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

321, 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 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. Updated on a regular basis,

the CDRH home page includes the guidance document ``Guidance on the

Recognition and Use of Consensus Standards,'' as well as the list of

recognized standards and details on their application, and information

on obtaining copies. 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.

VI. Comments

Interested persons may, at any time, submit to the contact person

listed 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 will be

considered in determining whether to amend the current guidance.

Dated: October 8, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

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[FR Doc. 98-27738 Filed 10-15-98; 8:45 am]

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