The Medical Device Business Journal — Medical Device News & Articles | MassDevice
MASSDEVICE ON CALL — Nearly two years and $1.3 million dollars after the FDA asked the Institute of Medicine to review the watchdog agency’s fast-track 510(k) medical device clearance process, the IOM’s conclusion on how to improve the system is to get rid of it completely.
The 22-month, independent IOM review, commissioned in 2009 by the FDA’s Center for Devices & Radiological Health, is not binding on the agency but is sure to cause a stir in med-tech circles.
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:
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.
MASSDEVICE ON CALL — Health insurance providers may have to offer prescription contraception at no up-front cost to women if Health & Human Services secretary Katherine Sebelius accepts the recommendations of the Institute of Medicine.
Boston Scientific Corp. (NYSE:BSX) lauded the recent Institute of Medicine audit of the state of pain and pain management in the U.S., which was mandated by the Patient Protection and Affordable Care Act of 2010.
The report estimates that 116 million American adults suffer from chronic pain, more than those affected by heart disease, cancer and diabetes combined.
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.
