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Guidance on Device Adaptive Clinical Study Designs


Federal Register Notice: FDA is making available a draft guidance entitled Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff. This guidance 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 defined as a clinical trial design that allows for prospectively planned modifications based on accumulating study data without undermining the trial's integrity and validity. To download this guidance, click here. To view this notice, click here.