In Brief: 510(k) paradigm
This article was originally published in The Gray Sheet
Executive Summary
510(k) paradigm: FDA announces the availability of "A New 510(k) Paradigm -- Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications" in the Sept. 19 Federal Register. The guidance outlines proposals for "special" and "abbreviated" 510(k)s ("The Gray Sheet" June 23, p. 5). Comments on the proposal are due by Nov. 18...