Regulatory Insights | Breakthrough Device Designation Program (Part 1)

Getting a medical device through the FDA's approval process and to the patients who need them is no small feat. Join Kwame Ulmer for relevant and timely regulatory insights that provide important information to help medical device manufacturers make strategic decisions that helps them get their products over regulatory hurdles and to market faster.

In FDA in a Minute's first episode, Kwame Ulmer shares implications of the FDA's updated Breakthrough Device Designation Program and what it means for medical device companies looking to expedite their submission and path to market.