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Senate committee proposes updates to FDA application requirements for reusable devices
In a recent session, the Senate Committee on Health, Education, Labor and Pensions favorably reported a bill requiring manufacturers of reusable medical devices to submit cleaning instructions and validation data to the FDA before bringing these devices to market. The bill also would require the FDA to develop guidance on when manufacturers should seek clearance from the agency before marketing their products.The “Preventing Superbugs and Protecting Patients Act” (S. 2503), sponsored Sen. Patty Murray, D-Wash., references several incidents of drug-resistant infections related to closed-channel duodenoscopes brought to light in the (Read more...)