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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2006-D-0410] (formerly Docket No. 2006D-0191)

# 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                           ( print 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