[Federal Register Volume 63, Number 200 (Friday, October 16, 1998)]
[Notices]
[Pages 55617-55630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27738]


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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Recognized Standards; Availability; Withdrawal of Draft Guidance ``Use 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draft guidance entitled ``Use of IEC 60601 Standards; Medical 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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