Posts tagged Expedited Access Pathway.
Blogs
2 minute read
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 ...
Back to Health Law Advisor Blog
Recent Updates
- CMS Wants to End Certain COVID Requirements, Natural Light in Patient Care Areas: Proposed Rule Would Update CoPs for Hospitals, LTC Facilities, and Other Providers
- The Structural Pressures Behind Senior Living and Long-Term Care Distress
- CMS Proposed Rule to Implement Section 6224 of the Consolidated Appropriations Act
- FDA Finalizes Key Parts of Its NDIN Guidance Related to Identity and Safety Information: What Dietary Supplement Companies Should Know
- The Whistleblower Windfall? DOJ Announces Another Incentive Program for Reporting Fraud