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.