The Institute of Medicine will hold an online press conference on the much-anticipated independent review of the FDA’s 510(k) clearance program for medical devices at 11:00 a.m. this morning.
The report’s conclusion that the watchdog agency should scrap the 510(k) medical device clearance process in its entirety has already drawn plenty of criticism.
- FDA: 510(k) times increasing because of poor submissions
- The FDA’s real record on medical device recalls
- The medical device industry tees off
- FDA punts on tough 510(k) moves
- FDA announces 510(k) changes
- Industry reacts to proposed changes to the 510(k) program
- FDA taps Institutes of Medicine to audit 510(k) process