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

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

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

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.



By | 2011-06-30T00:00:00+00:00 June 30th, 2011|FDA News|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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