Why Designing a Trial and Endpoints are Important: Markham C. Luke, M.D., Ph.D.
Device Development Luncheon: From Funding to Freedom to Operate Office of Device Eval–43 sec risk-based classification of medical devices–2:38 SE–3:26 humanitarian device exemptions–4:29 IDE–4:55 importance of clinical studies–6:58 submission types–8: Keyword(s): 510k, CDRH, clinical trials, collaboration, device development, endpoints, engineers, FDA, HDE, IDE, medical devices, Office of Device Evaluation, OUS, Pediatric Medical Device Safety & […]