[Federal Register: December 13, 2002 (Volume 67, Number 240)]
[Notices]
[Page 76749]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de02-65]
[[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availability of the draft guidance entitled ``Class II Special Controls
Guidance Document: Arrhythmia Detector and Alarm; Draft Guidance for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diskette of the draft guidance document entitled ``Class II Special
Controls Guidance Document: Arrhythmia Detector and Alarm; Draft
Guidance for Industry and FDA,'' to the Division of Small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