[Federal Register Volume 74, Number 176 (Monday, September 14, 2009)]
[Notices]
[Page 46996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22019]
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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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``Clinical Study Designs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This draft guidance provides FDA's proposed recommendations on clinical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 This draft guidance is not final nor is it in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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Clinical Study Designs for Surgical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 Submit written comments concerning this draft guidance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 [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 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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