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GUIDANCE DOCUMENT

Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version) February 2010

Final
Docket Number:
FDA-2006-D-0410
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

This guidance provides FDA's current thinking on use of baysian statistics in medical device clinical trials.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2006-D-0410.