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Guidance on Device Adaptive Clinical Study Designs


Federal Register Notice: FDA is making available a guidance entitled Adaptive Designs for Medical Device Clinical Studies. It provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. An adaptive design for a medical device clinical study is a design that allows for prospectively planned modifications based on accumulating study data without undermining the trial’s integrity and validity. Adaptive designs can reduce resource requirements and/or increase the chance of study success. To download this guidance, click here. To view this notice, click here.