On December 18, 2018 the Food and Drug Administration (“FDA”) finalized guidance on its existing Breakthrough Device Program and announced plans for advancement of the Safer Technologies Program (“STeP”). In the announcement, FDA Commissioner Scott Gottlieb emphasized the FDA’s efforts to promote innovation in medical devices that advance patient safety. This new medical device guidance could signal a year of opportunity for innovative medical device manufacturers that seek to advance patient safety.
Breakthrough Device Program
The Breakthrough Device ...
Blog Editors
Recent Updates
- The Civil Commitment Executive Order: Mixed Messages for Behavioral Health Stakeholders, State, and Local Governments
- AI Infrastructure, Ideology, and Exports: Inside the White House’s New AI Orders
- Texas Judge Strikes Down HIPAA’s Reproductive Health Amendment
- White House AI Action Plan Drops: Here’s What We Know
- AI Policy Alert: What to Know Before the White House Releases Its AI Action Plan