Demystifying the Process of Approaching the FDA as a MedTech Innovator

Event description

Presenter: Kwame Ulmer

After 12 years working for the FDA and personally evaluating over 1,000 medical technologies, Mr. Kwame Ulmer is ideally positioned to share insights on the process of approaching the FDA as a MedTech innovator. In this educational webinar, Kwame will provide an introduction to the FDA and regulatory issues, tailored to innovators that have not reached the FDA previously. He will also provide practical tips for digesting, distilling, and understanding guidance documents for engaging the FDA as a MedTech innovator.

Presenter Kwame Ulmer brings nearly twenty years of experience evaluating medical technologies in the government and serving in senior operating roles at medical device companies. He is currently an Entrepreneur-in-Residence at NHLBI and an active MedTech executive, lecturer, and researcher.

Seminar presented on March 11, 2022 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.