Document ID: FDA-2009-D-0395-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff: Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Availability
Posted Date: 2009-09-14T04:00Z

[Federal Register: September 14, 2009 (Volume 74, Number 176)]
[Notices]               
[Page 46996]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14se09-60]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0395]

 
Draft Guidance for Industry and Food and Drug Administration 
Staff; Clinical Study Designs for Surgical Ablation Devices for 
Treatment of Atrial Fibrillation; 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availability of the draft guidance entitled ``Clinical Study Designs 
for Surgical Ablation Devices for Treatment of Atrial Fibrillation.'' 
This draft guidance provides FDA's proposed recommendations on clinical 
trial designs for surgical ablation devices intended for the treatment 
of atrial fibrillation. This draft guidance is not final nor is it in 
effect at this time.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by December 14, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Clinical Study Designs for Surgical 
Ablation Devices for Treatment of Atrial Fibrillation'' to the Division 
of Small Manufacturers, International, and Consumer Assistance, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993. 
Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance. Submit written comments concerning this draft guidance 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.regulations.gov. Identify 
comments with the docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Elias Mallis, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1312, Silver Spring, MD 20993, 301-796-6216.

SUPPLEMENTARY INFORMATION:

I. Background

    Atrial fibrillation (AF) is a complex arrhythmia of the heart. Its 
precise mechanisms remain unclear. This draft guidance describes 
elements of suggested clinical study design for surgical ablation 
devices used to treat patients with longstanding persistent AF and 
patients with symptomatic paroxysmal AF, such as inclusion and 
exclusion criteria and assessment of effectiveness, which may differ 
for these patient populations.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on clinical 
study designs for surgical ablation devices for treatment of atrial 
fibrillation. 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 requirements of the 
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To receive ``Clinical Study Designs for 
Surgical Ablation Devices for Treatment of Atrial Fibrillation,'' you 
may either send an e-mail request to dsmica@fda.hhs.gov to receive an 
electronic copy of the document or send a fax request to 301-847-8149 
to receive a hard copy. Please use the document number 1676 to identify 
the guidance you are requesting.
    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 at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 
collections of information in 21 CFR part 812 have been approved under 
OMB control number 0910-0078; the collections of information in 21 CFR 
50 and 21 CFR 56 have been approved under OMB control number 0910-0130; 
and the collections of information under 21 CFR part 814 have been 
approved under OMB control number 0910-0231.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: August 28, 2009.
Catherine M. Cook,
Associate Director for Regulations and Policy, Center for Devices and 
Radiological Health.
[FR Doc. E9-22019 Filed 9-11-09; 8:45 am]

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