FDA 510(k) Clearance – An Overview
By Eric Thorn, Esq. Well to start off with, no a 510(k) is not some type of retirement plan, that’s a 401(k). Section 510(k) is a section of the Food, Drug and Cosmetic Act (FD&C Act) that requires device manufacturers to provide the Food and Drug Administration (FDA) with at least 90-day advance notice of…