[Federal Register Volume 68, Number 208 (Tuesday, October 28, 2003)]
[Notices]
[Pages 61448-61449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27114]


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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://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://www.fda.gov/cdrh. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/cdrh/guidance.html. 
Guidance documents are also available on the Division of Dockets 
Management Internet site at 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