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 & Improvement Act, pediatrics, PMA, risk-based classification, scientific evidence, SE

Video Uploaded By:

SAGES Webmaster

Uploaded on

07/20/2010

Video Categories

Device Development Luncheon, Meeting Content, SAGES 2010 Meeting

Learning Themes

Professional / Economic

Sources

2010 Annual Meeting

Presentation Types

Podium Presentation

Video Authors

Luke M

Video Institutions

CDRH--Silver Spring MD, FDA--Silver Spring MD

Average Rating

SAGES Member Discussion