Survey: 64 Percent of Devicemakers Dissatisfied With Handling of 510(k)s

A majority of devicemakers are unhappy with the way CDRH handles 510(k) submissions, according to a study by the Minnesota Medical Device Alliance. Nearly 200 medtech executives responded to the nationwide survey, which was conducted by a Minneapolis public relations firm. Of those, 51 percent were regulatory affairs professionals, 41 percent were executives and the remaining 8 percent filled other roles.
Devices & Diagnostics Letter