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

Streszczenie

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.