Adaptive Designs for Medical Device Clinical Studies (FDA)

Guidance on planning and implementing adaptive designs for clinical studies used in medical device development. It includes definitions, when to choose adaptive designs, using adaptive designs in blinded and unblinded studies, examples of various adaptive designs and potential challenges. Also recommends consulting with FDA in developing adaptive trials, and applies to PMA, 510(k), de novo, humanitarian, and investigational device exemption submissions at all trial stages.