FDA issued a draft “Guidance for Use of Bayesian Statistics in Medical Device Clinical Trials”.

-Section 3.5 states that the only software currently available is a noncommercial program called WinBUGS (and provides a link for downloading it) and recommends consultation with FDA statistician prior to data analyis regarding your choice of software as new programs become available.
– Section 3.9 under subheading “Checking calculation” states that “Since the software used in Bayesian analysis is relatively new, FDA will often verify results using alternate software. FDA recommends you submit your data and any programs used for Bayesian statistical analyses electronically.”

The full draft guidance is at the link provided.