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Latest From Sue Darcey
There is a 1-in-225 to 1-in-580 risk that women getting fibroid removal surgery through hysterectomies or myomectomies may have hidden uterine sarcomas, US FDA said Dec. 14, and verified that power morcellation use during the surgeries will result in higher rates of cancer recurrence.
President Trump signed off on legislation allowing US FDA to authorize additional emergency uses for medical products to reduce deaths and impacts of injuries caused by "agents of war." The signature ends a turf battle between FDA and the Department of Defense over authorizing products needed quickly under the emergency conditions of war.
A US FDA Orthopedics Advisory Panel voted 8-5 that the benefits do not outweigh the risks of implanting Intrinsic Therapeutics Inc.' Barricade prosthesis based on safety concerns, in particular a tendency for the device to break and separate into the lumbar column post implantation. Also, some panel members were not convinced that the device would improve patient function or allow people to return to their jobs.
FDA intends to draft a guidance by March outlining a voluntary, alternative 510(k) pathway for sponsors to demonstrate the substantial equivalence of some products by relying more on objective performance criteria.
Congress managed to temporarily stave off a government shutdown, but a continuing resolution bill passed Dec. 7 gives lawmakers only two more weeks – until Dec. 22 – to come up with a final budget plan for 2018. Meanwhile, a deal to raise the debt ceiling, allowing more spending next year, still needs to be set.
Sen. Al Franken, D-Minn., who has championed key device regulatory reform changes favoring the medtech industry that are now law, will step down from his post, following newly revealed charges of sexual harassment by a former congressional staffer in 2006.