Notice: Guidance for Industry and Food and Drug Administration; Guidance 
for the Use of Bayesian Statistics in Medical Device Clinical Trials; 
Availability

Federal Register: February 8, 2010 (Volume 75, Number 25)               
                  Page 6209-6210

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Guidance for the Use of 
Bayesian Statistics in Medical Device Clinical Trials.'' This guidance 
summarizes FDA's current thoughts on the appropriate use of Bayesian 
statistical methods in the design and analysis of medical device 
clinical trials.

DATES:  Submit electronic or written comments on agency guidances at 
any time.

ADDRESSES:  Submit written requests for single copies of the 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, Center for 
Devices and Radiological Health (CDRH), Food and Drug Administration, 
Bldg. 66, rm. 4617, 10903 New Hampshire Ave., Silver Spring, MD 20993 
or to the Office of Communication, Outreach and Development (HFM-40), 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist that office in processing your 
request, or fax to CDRH at 301-847-8149. The guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See 
the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance.
    Submit electronic comments to http://www.regulations.gov. Identify 
comments with the docket number found in brackets in the heading of 
this document. 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.

FOR FURTHER INFORMATION CONTACT:
    Greg Campbell, Center for Devices and Radiological Health, Bldg. 
66, rm. 2110, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 301-796-5750; or
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    This 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 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. Additionally, some ideas on

[[Page 6210]]

using Bayesian methods in post-market studies are presented.
    The draft version of this document was issued on May 23, 2006, for 
comment. A public meeting to discuss the document was held on July 27, 
2006. FDA received several hundred specific comments on the guidance. 
There were many comments of a specific technical nature; for example, a 
set of comments regarding our discussion of prior distributions, the 
meaning of ``non-informative'' priors, and how we might evaluate the 
choice of a prior led us to make some changes and additions to the 
document. As another example, the central importance of the concept of 
``exchangeability'' was revealed in some of the comments and has 
recently become more apparent; thus the discussion of exchangeability 
has been greatly expanded. Many comments of a more regulatory nature 
(e.g. specific issues regarding implementation of Bayesian methods in a 
regulatory setting) were also addressed in the revision. To the extent 
possible, editorial comments regarding the presentation of the 
statistical or technical issues and/or the writing were addressed.

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 ``Guidance for the 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

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. To receive ``Guidance for the Use of Bayesian 
Statistics in Medical Device Clinical Trials,'' 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 1601 to identify the guidance you 
are requesting. 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 or the CBER 
Internet site at http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

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 807 have been approved under 
OMB control number 0910-0120; the collections of information in 21 CFR 
part 812 have been approved under OMB number 0910-0078; the collections 
of information in 21 CFR part 814 have been approved under OMB control 
number 0910-0485; and the collections of information in 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), electronic or written 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: January 15, 2010.
Jeffrey Shuren,
Director, Center for Devices and Radiological Health.
[FR Doc. 2010-2596 Filed 2-5-10; 8:45 am]
BILLING CODE 4160-01-S