Premarket evidence generation

Premarket evidence generation and evaluation for surgical medical devices

11:00 am  FDA’s premarket evaluation: Methodological opportunities of the Highlights of the new FDA initiatives (Greg)ODE)

11:20 am The IDEAL recommendations for early phase studies:  (registers for first-in-man;
prospective study design and reporting recommendations for early phase studies;     prospective collaborative databases ) (TBD- IDEAL member)

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