Posts Tagged ‘ 510 (k) ’

Former FDA Director Joins Public Citizen in Device Recall Petition

Dec 23rd, 2011 | By
Former FDA Director Joins Public Citizen in Device Recall Petition

DECEMBER 23, 2011 ~ The consumer group Public Citizen frequently calls for the recall of dangerous drugs or medical devices including a petition last August calling for the recall of synthetic surgical mesh from the market because of the complication rate and a failure to show a benefit over risk (here).  Share this:



Push to More Regulation Heats Up FDA Expert Panel on Surgical Mesh

Sep 9th, 2011 | By
Push to More Regulation Heats Up FDA Expert Panel on Surgical Mesh

SEPTEMBER 8, 2011 – About the only thing that the room full of injured patients, industry representatives, and surgeons could agree on at the first FDA hearing on synthetic surgical mesh was that more studies are needed on the safety and efficacy of the controversial medical device. This was the first of a two-day expert
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U.S. Advisers Call for New Medical Device Regime, Reuters July 29, 2011

Aug 14th, 2011 | By
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
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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.