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. Read More
