Propel Medical Device Executive Webinar Series: Are Your Products Ready for the FDA’s New Digital Health Pre-Cert Program?

Webinar (PT)

Bradley Merrill Thompson, Member of the Firm, will co-present "Are Your Products Ready for the FDA’s New Digital Health Pre-Cert Program?" in Part 1 of the Propel Medical Device Executive Webinar Series.

Is your company developing or planning to develop a software product that meets the definition of a medical device?

On January 7, 2019, FDA published its draft working model for a new precertification program, to supplement its medical device approval process for software which functions as a medical device. It's a markedly different approach from how they regulate medical devices and new drugs. The FDA recognized that the traditional regulatory methodology is not well suited for the fast-paced, iterative-design development used for digital health software products.

This panel will outline the new digital health software regulations and answer attendee questions, such as:

  • Is my company eligible for the program?
  • What does it mean to be pre-certified?
  • What are the risks of non-participation?

For more information, visit Propelplm.com