FDA: CDRH Plan of Action on 510(k), June 15, 2011

Jun 30th, 2011 | By | Category: FDA


This FDA Plan of Action (here)  outlines 25 specific actions and accompanying timelines to make the 510(k) program “a blueprint for smarter medical device oversight; one that drives innovation and brings important technologies to patients.”

You’ll recall, the Institute of Medicine in 2011 issued a report that concluded the 510(k) fast-track approval process which allows device manufacturers to bypass safety and efficacy requirements, is “fatally flawed” and should be abolished.

Thousands of medical devices are approved this way every year, including some that are permanently implanted.

 

 

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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.