[Federal Register: July 1, 2002 (Volume 67, Number 126)]
[Notices]
[Page 44218-44219]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jy02-83]
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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