
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.
Tune in to the live webcast.
More on the push to reform the 510(k) program:
- 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