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BioWorld - Tuesday, April 7, 2026
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Home » Washington roundup: FDA hints at statutory fix for 510(k) changes issue
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Washington roundup: FDA hints at statutory fix for 510(k) changes issue

June 17, 2013
By Mark McCarty
FDA's stakeholder meeting on the 510(k)-changes issue offered a range of views, but the agency's representatives indicated their interest in the issue has not waned despite pushback from Capitol Hill last year. FDA's Michael Ryan, a regulatory advisor, said the current regulatory regime "is a little open to interpretation" as to what sort of changes might trigger a new 510(k) filing, and indicated the agency will press the matter with Congress by remarking that some of the changes FDA would make to a 1997 guidance could require new legislation.
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