[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Page 11207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03487]



[[Page 11207]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Clinical Study Designs for Surgical Ablation Devices for 
Treatment of Atrial Fibrillation; Guidance for Industry and Food and 
Drug Administration Staff; 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 ``Clinical Study Designs for 
Surgical Ablation Devices for Treatment of Atrial Fibrillation.'' This 
guidance provides FDA's recommendations on clinical trial designs for 
surgical ablation devices intended for the treatment of atrial 
fibrillation.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the 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 20993-0002. 
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 electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Libet Garber, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1254, Silver Spring, MD 20993-0002, 301-796-6912.

SUPPLEMENTARY INFORMATION:

I. Background

    Atrial fibrillation (AF) is a complex arrhythmia of the heart. This 
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. In the Federal Register of 
September 14, 2009 (74 FR 46996), FDA announced the availability of the 
draft guidance document. Interested persons were invited to comment by 
December 14, 2009. Three sets of comments were received with 
recommendations related to definitions and certain elements of the 
recommended study design(s), such as study endpoints, endpoint 
assessments, appropriate control groups, and followup of study 
subjects. In response, FDA revised the guidance document to address the 
comments and clarify our recommendations as appropriate. This guidance 
supersedes the draft guidance entitled ``Clinical Study Designs for 
Surgical Ablation Devices for Treatment of Atrial Fibrillation,'' dated 
September 14, 2009.

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 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 guidance may do so by 
using the Internet. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Clinical Study Designs for Surgical Ablation Devices for Treatment of 
Atrial Fibrillation,'' you may either send an email request to 
[email protected] 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 1708 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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 
part 807, subpart E, have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR parts 50 and 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 either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03487 Filed 2-14-13; 8:45 am]
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