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
humanitarian device exemptions–4:29
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 & Improvement Act, pediatrics, PMA, risk-based classification, scientific evidence, SE

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    SAGES Webmaster on Jul 20, 2010
    This video was accepted for presentation at the 2010 SAGES Scientific Session via a peer-review process

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