An Afternoon with the FDA – Webinar Recap

The National Institutes of Health (NIH) Commercialization Accelerator Program (CAP) [NIH CAP], Larta Institute, and the Food & Drug Administration (FDA) presented “An FDA Afternoon” online webinar on March 31.  This event was for HHS/NIH SBIR/STTR small businesses and others interested in learning more about how businesses can communicate and interact with the FDA and access FDA resources, as well as information and insights for what to consider when communicating with the FDA.  The presentations included CDER (drugs), CDRH (devices), and CMS (Medicare/Medicaid Services), and the underlying theme for small businesses with new technologies needing FDA clearance was “get organized and start the dialog early.”

SESSION 1: Speaker: F. Ray Ford, Jr

Content: CDER 101 – This session provided a basic understanding of how to effectively communicate with FDA re drug development.  (Presentation slides not available – see CDER website)

SESSION 2: Speaker: Danielle Fau

Content: CDRH 101 – This session provided important insights for accessing resources from CDRH, interacting with CDRH review teams, staying current on special programs, and considering market access earlier in the device lifecycle.

(Download Presentation from Danielle Fau – CDRH)

SESSION 3: Speaker: Rochelle Fink

Content: This session provided an overview of CMS – coverage, reimbursement; coding and what you need to consider to successfully approach CMS. (Presentation slides not available – see CMS website)

Here are some additional resources that relate to the conversation during the webinar:

1.       EUA link

2.       FDA’s Centralized COVID-19 Website

3.       Breakthrough Devices Program

4.       CDRH Innovation

Larta Institute partnered with NIH and FDA to present this event.  If you have any questions, Larta lists these contacts: Josefina Correa, Program Manager at  or Judy Hsieh, Program Director at .