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
- Last Call for Comments on the Bipartisan Discussion Draft of the SUSTAIN Act: Shaping 340B for the Future
- Indiana Senate Enrolled Act 9 Requires Written Notice of Health Care Entities’ Mergers or Acquisitions
- Connecticut Bill Calls for Office of Health Strategy to Develop a Plan Regarding Private Equity Firms in Health Care
- Revised OCR Guidance Provides New Examples, but Raises More Questions, Regarding Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates
- FDA Releases Draft Guidance on New Dietary Ingredient Notification Procedures, Timelines