[Federal Register Volume 67, Number 240 (Friday, December 13, 2002)]
[Notices]
[Page 76749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31439]



[[Page 76749]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0421]


Medical Devices; Class II Special Controls Guidance Document: 
Arrhythmia Detector and Alarm; 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availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: Arrhythmia Detector and Alarm; Draft Guidance for 
Industry and FDA.'' Elsewhere in this issue of the Federal Register, 
FDA is publishing a proposed rule to reclassify the arrhythmia detector 
and alarm from class III (premarket approval) to class II (special 
controls). If the device is reclassified, FDA intends that this 
guidance document will serve as the special control. This guidance is 
neither final nor is it in effect at this time.

DATES: Submit written or electronic comments concerning this guidance 
by March 13, 2003.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Class II Special 
Controls Guidance Document: Arrhythmia Detector and Alarm; Draft 
Guidance for Industry and FDA,'' to the Division of Small 
Manufacturers, International, and Consumer Assistance (HFZ-220), Center 
for Devices and Radiological Health, 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 
information on electronic access to the guidance.
    Submit written comments concerning this guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket 
number found in brackets in the heading of this document. Submit 
electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Carole C. Carey, Center for Devices 
and Radiological Health (HFZ- 450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8609.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a proposed rule to reclassify the arrhythmia detector and alarm from 
class III (premarket approval) to class II (special controls). This 
draft guidance document describes a means by which arrhythmia detector 
and alarm (including ST-segment measurement and alarm) devices may 
comply with the requirement of special controls for class II devices. 
Designation of this guidance document as a special control means that 
manufacturers attempting to establish that their device is 
substantially equivalent to a predicate arrhythmia detector and alarm 
(including ST-segment measurement and alarm) device should demonstrate 
that the proposed device complies with either the specific 
recommendations of this guidance or some alternate control that 
provides equivalent assurances of safety and effectiveness.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the agency's current thinking on special controls for the arrhythmia 
detector and alarm. 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 and regulations.

III. Electronic Access

    In order to receive ``Class II Special Controls Guidance Document: 
Arrhythmia Detector and Alarm; Draft Guidance for Industry and FDA'' 
via your fax machine, call the CDRH Facts-On-Demand system at 800-899-
0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the 
system. At the second voice prompt press 1 to order a document. Enter 
the document number (1363) followed by the pound sign ([numsign]). 
Follow the remaining voice prompts to complete your request.
    You may obtain a copy of the draft guidance from the Internet. CDRH 
maintains an entry on the Internet for easy access to information 
including text, graphics, and files that you may download to a personal 
computer. Updated on a regular basis, the CDRH home page includes 
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. You may access the CDRH home 
page at http://www.fda.gov/cdrh. You may search for all CDRH guidance 
documents at http://www.fda.gov/cdrh/guidance.html. Guidance documents 
are also available on the Dockets Management Brach Internet site at 
http://fda/gov/ohrms/dockets.

IV. Comments

    Interested persons may submit to Dockets Management Branch (see 
ADDRESSES) written or electronic comments on this draft guidance by 
(see DATES). Two copies of any comment 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. The 
draft guidance document and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: October 23, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-31439 Filed 12-12-02; 8:45 am]
BILLING CODE 4160-01-S