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Institute of Medicine

IOM slams the FDA’s 510(k) medical device review process

July 29, 2011 By MassDevice staff Leave a Comment

MassDevice On Call

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.

Filed Under: Food & Drug Administration (FDA), Healthcare Reform, Mammography, News Well, Regenerative Medicine Tagged With: 510(k) reforms, Breast Cancer, Institute of Medicine

IOM live briefing set for this morning

July 29, 2011 By MassDevice staff Leave a Comment

Eye on the FDA

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.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: 510(k) reforms, Institute of Medicine

FDA Report: Eight recommendations

July 29, 2011 By MassDevice staff Leave a Comment

FDA

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.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: 510(k) reforms, Institute of Medicine

510(k) reform: FDA’s medical device unit review due out Friday

July 27, 2011 By MassDevice staff Leave a Comment

FDA

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.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: 510(k) reforms, Institute of Medicine

With liberty and contraception for all

July 20, 2011 By MassDevice staff Leave a Comment

MassDevice On Call

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.

Filed Under: Food & Drug Administration (FDA), Health Information Technology, Healthcare Reform, Legal News, News Well, Women's Health Tagged With: Centers for Disease Control & Prevention (CDC), Institute of Medicine

Boston Scientific welcomes report on U.S. pain management

July 5, 2011 By MassDevice staff Leave a Comment

Boston Scientific

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.

Filed Under: Neuromodulation/Neurostimulation, News Well, Pain Management Tagged With: Boston Scientific, Institute of Medicine

510(k) reform: IOM finally asks for medical device representation

April 1, 2011 By MassDevice staff Leave a Comment

FDA logo

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.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: 510(k) reforms, Institute of Medicine

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