[Federal Register: October 28, 2003 (Volume 68, Number 208)]
[Notices]
[Page 61448-61449]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc03-66]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D-0421]
Guidance for Industry and FDA Staff on 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 guidance document entitled ``Class II Special
Controls Guidance Document: Arrhythmia Detector and Alarm.'' This
guidance document describes a means by which arrhythmia detector and
alarm devices may comply with the requirement of special controls for
class II devices. Elsewhere in this issue of the Federal Register, FDA
is publishing a final rule to reclassify these devices from class III
into class II (special controls).
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Class II Special Controls
Guidance Document: Arrhythmia Detector and Alarm'' to the Division of
Small Manufacturers, International, and Consumer Assistance (HFZ-220),
Center for Devices and Radiological Health (CDRH), 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.
Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document. See
the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance.
FOR FURTHER INFORMATION CONTACT: Elias Mallis, CDRH (HFZ-450), Food and
Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-
443-8517, ext 177.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 13, 2002 (67 FR 76749), FDA
announced the availability of a draft of this guidance document and
invited interested persons to comment on it by
[[Page 61449]]
March 13, 2003. FDA received one comment. The comment suggested that
FDA rely on more recent technical standards and, in some cases,
suggested alternate methods and standards to those FDA cited in the
draft guidance. FDA revised the guidance to reflect the updated
technical standards, but declined to incorporate the alternate
standards and methods suggested. As discussed next, however, a firm may
meet the recommendations of the guidance or in some other way provide
equivalent assurances.
The 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. Following the effective date of the final classification rule,
any firm submitting a 510(k) premarket notification for the device will
need to address the issues covered in the special control guidance.
However, the firm need only show that its device meets the
recommendations of the guidance or in some other way provides
equivalent assurances of safety and effectiveness.
Also in the Federal Register of December 13, 2002 (67 FR 76706),
FDA proposed to reclassify the arrhythmia detector and alarm into class
II with this guidance document as the special control. FDA did not
receive any comments on the proposed rule. Elsewhere in this issue of
the Federal Register, FDA is publishing a final rule to reclassify the
arrhythmia detector and alarm from class III (premarket approval) to
class II (special controls).
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the FDA's
current thinking on arrhythmia detector and alarm devices. The guidance
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
To receive ``Class II Special Controls Guidance Document:
Arrhythmia Detector and Alarm'' by 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.
Persons interested in obtaining a copy of the guidance may also do
so by using the Internet. CDRH maintains an entry on the Internet for
easy access to information, including text, graphics, and files that
may be downloaded to a personal computer with Internet access. 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 manufacturer's assistance, information on video
conferencing and electronic submissions, Mammography Matters, and other
device-oriented information. The CDRH Web site may be accessed at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of Dockets
Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 USC 3501-3520). The
collections of information addressed in the guidance document have been
approved by OMB in accordance with the PRA under the regulations
governing premarket notification submissions (21 CFR part 807, subpart
E, OMB control number 0910-0120). The labeling provisions addressed in
the guidance have been approved by OMB under the PRA under OMB control
number 0910-0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document
at any time. Submit a single copy of electronic comments or two paper
copies of any mailed comments, 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. Comments received may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: October 2, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27114 Filed 10-27-03; 8:45 am]
BILLING CODE 4160-01-S