[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Use of IEC 60601 Standards; Medical Electrical Equipment; Draft
Guidance; Availability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availability of a draft guidance entitled ``Use of IEC 60601 Standards;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 The purpose of the draft guidance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DATES: Written comments concerning this draft guidance must be received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ADDRESSES: Submit written comments concerning this draft guidance to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 Submit written requests for single copies of the draft
guidance to the Division of Small Manufacturers Assistance (DSMA),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INFORMATION section for electronic access to the draft guidance.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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