E6-7855. Draft Guidance for Industry and Food and Drug Administration Staff; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials; Availability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.

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials.” This draft guidance provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. This draft guidance is neither final nor is it in effect at this time.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Submit written or electronic comments on this draft guidance by August 21, 2006.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Submit written requests for single copies of the draft guidance document entitled “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials” to the Division of Small Manufacturers, International, and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 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This draft guidance outlines FDA's current thinking on the use of Bayesian statistical methods in medical device clinical trials.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 This draft guidance includes a general description of Bayesian methods, discussions on design and analysis of Bayesian medical device clinical trials, the benefits and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 Finally, the draft guidance presents some ideas on using Bayesian methods in postmarket studies.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.