"SPECIAL" 510(K) ROUTE COULD BE IMPLEMENTED BY FALL, FDA SAYS; THIRD-PARTY CONFORMANCE ASSESSMENT FOR SPECIAL, ABBREVIATED 510(K)S WOULD BE ALLOWED
This article was originally published in The Gray Sheet
Executive Summary
FDA's "special" 510(k) proposal to speed reviews of device modifications by relying on design control requirements could be implemented by this fall, agency staffers say.