- September 21, 2016
08:00 PM - 08:00 PM EDT
On July 27, 2016, the FDA published the Adaptive Designs for Medical Device Clinical Studies Final Guidance. It provides clarity on how to plan and implement adaptive designs for clinical studies used in medical device development. This final guidance applies to premarket medical device submissions including premarket approval applications (PMA), premarket notification (510(k)) submissions, de novo submissions, humanitarian device exemption (HDE) applications, and investigational device exemption (IDE) submissions. The Agency encourages companies to consider the use of adaptive design in their clinical trials.
FDA discussed this final guidance document at a webinar scheduled on Thursday September 22, 2016. The webinar was intended to help manufacturers and other interested stakeholders understand the information provided in this final guidance document. Following a brief presentation, the FDA responded to questions.