FDA Outlines Balance Between Premarket, Postmarket Device Studies

FDA issued final guidance giving specific examples of when the agency feels it is appropriate to use postmarket data in order to speed up the device premarket approval application (PMA) process. The guidance dovetails with a separate guidance, also issued Wednesday (April 8), launching the agency's Expedited Premarket Approval (EAP) program for medical devices intended for unmet medical needs, which is mirrored after expedited pathways for drugs. The first guidance suggests the agency may be willing to rely more heavily...