[Federal Register Volume 67, Number 126 (Monday, July 1, 2002)]
[Notices]
[Pages 44218-44219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16449]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0519]


Medical Devices; Cardiac Ablation Catheters Generic Arrhythmia 
Indications for Use; Guidance for Industry; 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 entitled ``Cardiac Ablation Catheters 
Generic Arrhythmia Indications for Use; Guidance for Industry.'' This 
document encourages manufacturers of approved conventional cardiac 
ablation catheters to submit supplements to broaden their labeling from 
arrhythmia-specific indications to a generic arrhythmic treatment 
indication. The Center for Devices and Radiological Health (CDRH) is 
issuing this guidance document to allow companies to label these 
products for a broader indication without submitting additional 
clinical information. This recommendation is based on a comprehensive 
search of the medical literature.

DATES:  Submit written or electronic comments on the guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance entitled ``Cardiac Ablation Catheters Generic 
Arrhythmia Indications for Use; Guidance for Industry'' 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.

[[Page 44219]]

    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. Comments should be identified with 
the docket number found in brackets in the heading of this document. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Lesley L. Ewing, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8320.

SUPPLEMENTARY INFORMATION:

I. Background

    This final guidance entitled ``Cardiac Ablation Catheters Generic 
Arrhythmia Indications for Use; Guidance for Industry'' recommends that 
manufacturers of approved conventional cardiac radiofrequency ablation 
catheters submit a premarket approval supplement to obtain a generic 
indication for creating endocardial lesions to treat arrhythmias. The 
guidance document provides evidence from the medical literature to 
support this broadening of indications from arrhythmia-specific 
indications to a generic arrhythmia treating indication.
    The guidance was made available as a draft for comment on December 
7, 2001 (66 FR 63546). The comment period closed March 7, 2002. FDA 
received two comments, both agreeing with FDA's recommendation. One of 
these comments also asked that FDA expand the definition of 
conventional cardiac catheter. FDA disagrees and is issuing the 
guidance with no changes.

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 
agency's current thinking on generic indications for cardiac ablation 
catheters. 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 applicable statute and 
regulations.

III. Electronic Access

    In order to receive the guidance entitled ``Cardiac Ablation 
Catheters Generic Arrhythmia Indications for Use; Guidance for 
Industry'' 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 (1382) 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 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 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. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/cdrh/guidance.html. 
Guidance documents are also available 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 (44 U.S.C. 3501-3520). The 
collection of information in the section on Generic Arrhythmia 
Indications in the guidance was approved under OMB control number 0910-
0231.

V. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this guidance at 
any time. 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. The 
draft guidance document and received comments may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: June 21, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-16449 Filed 6-28-02; 8:45 am]
BILLING CODE 4160-01-S