[Federal Register Volume 71, Number 99 (Tuesday, May 23, 2006)]
[Notices]
[Pages 29651-29652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7855]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0191]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Guidance for the Use of Bayesian Statistics in Medical Device 
Clinical Trials; 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availability of the draft guidance entitled ``Guidance for the Use of 
Bayesian Statistics in Medical Device Clinical Trials.'' This draft 
guidance provides FDA's recommendations on the use of Bayesian 
statistical methods in the design and analysis of medical device 
clinical trials. This draft guidance is neither final nor is it in 
effect at this time.

DATES: Submit written or electronic comments on this draft guidance by 
August 21, 2006.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Guidance for the Use of Bayesian 
Statistics in Medical Device Clinical Trials'' 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 one self-addressed adhesive 
label to assist that office in processing your request, or fax your 
request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments concerning this 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.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Greg Campbell, Center for Devices and 
Radiological Health (HFZ-542), Food

[[Page 29652]]

and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 
240-276-3127.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance outlines FDA's current thinking on the use of 
Bayesian statistical methods in medical device clinical trials. 
Bayesian statistical methods are currently used in a variety of medical 
device applications to FDA. This draft guidance includes a general 
description of Bayesian methods, discussions on design and analysis of 
Bayesian medical device clinical trials, the benefits and difficulties 
with the Bayesian approach, and comparisons with standard (frequentist) 
statistical methods. Finally, the draft guidance presents some ideas on 
using Bayesian methods in postmarket studies.

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 use of 
Bayesian statistics in medical device clinical trials. 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

    To receive ``Guidance for the Use of Bayesian Statistics in Medical 
Device Clinical Trials'' by fax, 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 (1601) 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 by 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 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 on the Division of 
Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

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 807 have been approved under 
0910-0120; the collections of information in 21 CFR part 812 have been 
approved under 0910-0078; the collections of information in 21 CFR part 
814 have been approved under 0910-0231; and the collections of 
information in 21 CFR part 822 have been approved under 0910-0449.

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. Comments received may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: May 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7855 Filed 5-22-06; 8:45 am]
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