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BioWorld - Wednesday, May 1, 2024
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» Industry sees US FDA’s predicates draft guidance as extralegal
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Industry sees US FDA’s predicates draft guidance as extralegal
Dec. 14, 2023
By
Mark McCarty
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The U.S. FDA’s draft guidance for selection of a predicate device in 510(k) submissions is part of a larger effort to overhaul the 510(k) program, but industry’s response is that this draft guidance goes too far.
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U.S.
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