[Federal Register Volume 63, Number 8 (Tuesday, January 13, 1998)]
[Notices]
[Pages 1974-1975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-751]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0530]


Use of IEC 60601 Standards; Medical Electrical Equipment; Draft 
Guidance; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Use of IEC 60601 Standards; 
Medical Electrical Equipment.'' The purpose of the draft guidance 
document is to provide guidance to the Office of Device Evaluation 
(ODE) 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.

DATES: Written comments concerning this draft guidance must be received 
by April 13, 1998.
ADDRESSES: Submit written comments concerning this draft guidance to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Comments should be 
identified with the docket number found in brackets in the heading of 
this document. Submit written requests for single copies of the draft 
guidance to the Division of Small Manufacturers Assistance (DSMA), 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 
request, or fax your request to 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Melvyn R. Altman, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 2094

[[Page 1975]]

Gaither Rd., Rockville, MD 20850, 301-594-4766 ext. 103.

SUPPLEMENTARY INFORMATION:

I. Background

    The IEC 60601 series of international consensus standards addresses 
many aspects of safety common to electrical medical devices. Some of 
these safety aspects pertain to mechanical, electric shock, fire, and 
electromagnetic compatibility. These standards are used worldwide and 
play a central role in the regulation of medical devices in the 
European Union, Canada, Australia, and other countries. They have 
undergone continuous scrutiny and revision with the participation of 
FDA staff. IEC 60601-1, the basic standard in the series, was first 
published in 1977 (as IEC 601-1). The second edition of IEC 60601-1 was 
published in 1988, and was subsequently amended in 1991 and 1995. A 
U.S. version of IEC 60601-1 (UL2601-1) is presently being balloted to 
become an American National Standard.
    The IEC 60601 series of standards consists of the following:

      A general (base) safety standard, IEC 60601-1;
      Collateral standards, IEC 60601-1-X, covering issues 
integral to the general standard but that are too expansive to be 
included in IEC 60601-1; and
      Particular standards, IEC 60601-2-XX, that tailor the 
general standard and collateral standards to specific devices by 
considering each requirement in them and determining if it should 
apply as stated, apply in modified form, or not apply at all.
The particular standards are ``customized'' versions of the general and 
collateral standards and can be used only with them.
    The agency has adopted Good Guidance Practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance document ``Use of IEC 60601 Standards; Medical 
Electrical Equipment'' is issued as a Level 1 guidance consistent with 
GGP's.

II. Overview

    A party submitting a premarket application (i.e., premarket 
notification (510(k)), investigational device exemption application 
(IDE), premarket approval application (PMA), humanitarian device 
exemption application (HDE), or product development protocol (PDP)) 
must provide information as required by the statute and regulations to 
allow FDA to make an appropriate decision regarding the clearance or 
approval of the submission. This guidance document describes FDA's 
intent to use information on conformance with the IEC 60601 standards 
to satisfy premarket review requirements, but does not affect FDA's 
ability to obtain any information authorized by the statute or 
regulations.
    FDA believes that conformance with the IEC 60601 standards provides 
a reasonable assurance of safety for many aspects of electromedical 
devices. Therefore, information on conformance with these standards 
will have a direct bearing on safety determinations made during the 
review of IDE's, HDE's, PMA's, and PDP's. In case of 510(k)s, 
information on conformance with the IEC 60601 standards will help 
establish the substantial equivalence of a new device to a legally 
marketed predicate device. This information can serve as a surrogate 
for comparative information to show that the new device is as safe as 
the predicate in the areas covered by the standards. Moreover, if a 
premarket submission contains a declaration of conformity to the IEC 
60601 standards, this will, in most cases, eliminate the need to review 
actual test data for those aspects of the device addressed by the 
standards. The content of a declaration of conformity is described in 
the guidance document and is consistent with the ISO/IEC Guide 22.
    Conformance with IEC 60601 standards in and of itself, however, may 
not always be a sufficient basis for regulatory decisions regarding 
safety. For example, a specific device may raise a safety issue not 
addressed by the standards, or a specific FDA regulation may require 
additional information beyond what conformity to the IEC 60601 
standards provides. Under such circumstances, conformity with these 
standards will not satisfy all requirements regarding safety for 
marketing, or investigating, the product in the United States.
    This guidance document represents the agency's current thinking on 
the use of IEC 60601 standards for medical electrical equipment. 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 requirements of the applicable statute, 
regulations, or both.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the World Wide Web (WWW). The Center for Devices and Radiological 
Health (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 WWW. Updated on a 
regular basis, the CDRH home page includes the guidance document ``Use 
of IEC Standards; Medical Electrical Equipment,'' 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 guidance document ``Use of IEC 60601 
Standards Medical Electrical Equipment'' will be available at http://
www.fda.gov/cdrh/ode/ecidraft.html.
    A text-only version of the CDRH WWW 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 FDA's 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.

IV. Comments

    Interested persons may, on or before April 13, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
the draft guidance. 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 may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday. Received comments 
will be considered in determining whether to amend the current draft 
guidance.

    Dated: November 25, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 98-751 Filed 1-12-98; 8:45 am]
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