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.

The Institutes of Medicine’s long-awaited review of the FDA’s medical device 510(k) process hit seven main points:

1. First and foremost, scrap the existing 510(k) program as quickly as possible. Replace the "substantial equivalence" standard that gives medical devices a pass for demonstrating that they are similar to already-cleared devices with a framework that focuses more heavily on premarket and postmarket surveillance.

The Institute of Medicine will release the highly anticipated results of its year-long investigation into the FDA’s medical device review process at the end of this week.

The IOM was tasked by the FDA to do a soup-to-nuts review of the program in late 2009 and many in the industry are fearful that the institute will call for sweeping changes and that the FDA will follow suit.

The Institute of Medicine is done with its review of the FDA’s 510(k) clearance protocol and wants to hear from the medical device industry about its findings.

Adding some med-tech voices to the panel could help quell persistent complaints that the medical device industry has been woefully under-represented in the FDA’s 510(k) reform process. The IOM’s independent review is part of the Food & Drug Administration’s push to revamp the protocol by which a vast majority of medical devices are cleared for market in the U.S.