Recommendations include raising standards of approval from “reasonable assurance” of safety to “substantial evidence” of safety, ensuring that implantable and life-sustaining devices do not go through the fast-tracked 510(k) process, requiring devices approved based on a recalled device are automatically reviewed for safety, implementation of a national unique identifier system to track safety issues, enabling the FDA to use its recall authority more effectively and providing the FDA with authority to call for longer term post-market studies. The letter comes before the reauthorization of the Medical Device User Fee Act.
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