Demystifying the Process of Approaching the FDA as a MedTech Innovator

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.

This seminar was presented on March 11, 2022 to an invited audience.

The Catalyze program utilizes a new approach to translational research by supporting both the technical needs of an innovation and the management, commercialization, regulatory, and training requirements of the innovators developing them. Projects supported by Catalyze receive funding and advisory support through the National Heart, Lung, and Blood Institute (NHLBI), as well as project management assistance, access to technical services and expertise, and training opportunities through the Catalyze Coordinating Center.

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

Webinar Bookmarks

00:00 Introduction/Experience
05:30 Regulatory Strategy
07:35 Considerations
11:10 Problems
12:30 Poll: What is Your Problem
15:50 Regulatory Risk Classes and Data
18:08 510(k) vs PMA
19:50 Regulatory Path (timeline) Digital Health Solution
21:48 Where can we get information about our product and predicates?
22:43 Product and Predicate Resources
22:48 Digital Health Landscape
23:10 Should we start talking to the FDA now?
25:00 Clinical Considerations
26:38 Should we start talking to an ISA 13485 Contract Manufacturer now?
27:50 How do I Prepare for a Meeting with the FDA?
28:37 How best to communicate your story in the FDA submission
29:33 Control the Narrative – How best to communicate your story in the FDA during the review process.
32:50 Discussion