FDA Guidance on Adaptive Designs released

On July 27^th, FDA released final guidance for Adaptive Designs for Medical Device Clinical Studies – a link to the guidance is here.  According to Zachary Brennan in his article posted on RAPS, FDA received 151 comments from industry and most were included in the final guidance.  The guidance explains that “An adaptive design for a medical device clinical study is defined as a clinical study design that allows for prospectively planned modifications based on accumulating study data without undermining the study’s integrity and validity.”  Examples are listed throughout the guidance to provide a better understanding of how to include this in your medical device clinical study planning.  Need help in planning your medical device clinical study?  Contact us here.