[Federal Register Volume 66, Number 236 (Friday, December 7, 2001)]
[Notices]
[Pages 63546-63547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30330]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0519]


Medical Devices: Draft Guidance on Cardiac Ablation Catheters 
Generic Arrhythmia Indications for Use; 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availability of the draft guidance entitled ``Cardiac Ablation 
Catheters Generic Arrhythmia Indications for Use.'' This draft guidance 
document encourages manufacturers of approved conventional cardiac 
ablation catheters to submit supplements to broaden their

[[Page 63547]]

labeling from arrhythmia-specific indications to a generic arrhythmic 
treatment indication. The Center for Devices and Radiological Health 
(CDRH) is issuing this draft guidance document to allow companies to 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. This draft guidance is 
neither final nor is it in effect at this time.

DATES: Submit written or electronic comments concerning this draft 
guidance by March 7, 2002.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance document entitled ``Cardiac Ablation Catheters 
Generic Arrhythmia Indications for Use'' 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. Submit written comments concerning this draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
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: Donna-Bea Tillman, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8517.

SUPPLEMENTARY INFORMATION:

I. Background

    The draft guidance document 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 draft guidance 
document provides evidence from the medical literature to support this 
broadening of indications from arrhythmia-specific indications to a 
generic arrhythmia treating indication.

II. Significance of Guidance

    The draft guidance document, when finalized, 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.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This draft guidance document is 
issued as a level 1 guidance in accordance with the GGP regulations.

III. Electronic Access

    In order to receive ``Cardiac Ablation Catheters Generic Arrhythmia 
Indications for Use'' 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 (#). Follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of the draft 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 the civil money penalty 
guidance documents package, 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. Guidance documents are also available on the Dockets Management 
Branch Web site at http://www.fda.gov/ohrms/dockets/default.htm.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments on the draft guidance by 
March 7, 2002. 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: November 28, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 01-30330 Filed 12-6-01; 8:45 am]
BILLING CODE 4160-01-S