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

Aug 14th, 2011 | By | Category: FDA, Media Reports

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.


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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.