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Tag Archives: 510 (k)

From U of Washington website

Former FDA Director Joins Public Citizen in Device Recall Petition

By Mesh Medical Device Newsdesk |

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). 

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

By Mesh Medical Device Newsdesk |

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 [continue reading…]

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

By Mesh Medical Device Newsdesk |

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 [continue reading…]

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