U.S. Advisers Call for New Medical Device Regime, Reuters July 29, 2011

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U.S. Advisers Call for New Medical Device Regime, Reuters July 29, 2011

The FDA is pushing back on an Institute of Medicine recommendation that the fast-track approval process for medical devices is fatally flawed and should be replaced, reports Reuters.

FDA’s Jeffrey Shuren, director of the Center for Devices and Radiological Health, which oversees devices, said the 510(k) process should not be eliminated, but “we are open to additional proposals and approaches for continued improvement of our device review programs.”

There were problems with devices such as the high-profile recall last year of the DePuy unit artificial hips (Johnson & Johnson), and automated external defibrillators. There were 4,000 devices cleared for market in 2009, most cleared through 510 (k).

The IOM suggested the FDA start collecting information to build the new process, including post-market data for devices. Congress should then enact legislation to design the regulatory framework, according to the report.

Read the report here.

 

By | 2011-08-14T04:21:25+00:00 August 14th, 2011|FDA News, Media Reports|0 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

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