NHLBI Catalyze Seminar: Gaining the Edge - Medical Device Products Development to Regulatory

Event description

Presenter: Diane Earp, BSMT, SBB(ASCP)

This presentation provides a general overview of the medical device landscape for a sound regulatory plan/strategy and explains how it can provide a competitive edge for product development. Additionally, the speaker provides a list of reference material and discusses the evolving framework for new devices and combination product clearance/approval by the US FDA.

Seminar presented on June 22, 2021 to an invited audience.

This video is provided for educational purposes only.

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This research was, in part, funded by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.