The FDA today released a pair of draft guidances on postmarket requirements for certain medical devices. The first guidance was written to help manufacturers of certain Class II (moderate-risk) and Class III (high-risk) devices for which the agency has issued a postmarket surveillance (522) order. The FDA may issue a 522 order at any time […]
postmarket
Critic questions FDA’s handling of Essure product complaints
FDA continues to update how it is informing the public about the controversial Essure permanent birth control device from Bayer. But at least one prominent critic sees holes in FDA’s efforts. “Many women are still being implanted with the device without adequate warnings of the risks associated with the device,” attorney Holly Ennis wrote in an […]