Tag Archives: 510 (k)
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).
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…]
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…]