Draft Guidance for Industry and Food and Drug Administration Staff; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials." This draft guidance provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. This draft guidance is neither final nor is it in effect at this time.