In May 2006 the FDA Center for Devices and Radiological Health (CDRH) released our draft “Guidance for the use of Bayesian statistics in medical device clinical trials.” The final version of that guidance should be released by the fall of 2009. This talk will discuss the final version of the guidance document, including comments on, and changes from, the previous version. In addition, I will discuss the simulations and sensitivity analyses that we often require for Bayesian submissions and their rationale from the regulatory point of view.