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BioWorld - Thursday, March 5, 2026
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» Industry sees need for clarity in FDA draft guidance for 510(k) transfers
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Industry sees need for clarity in FDA draft guidance for 510(k) transfers
Aug. 11, 2025
By
Mark McCarty
Eleven pages is relatively short for a modern U.S. FDA draft guidance, but two trade associations nonetheless had questions about the FDA draft for transfers of 510(k) devices, such as how the agency defines the holder of the 510(k).
Medical technology
Regulatory
U.S.
510(k)
FDA