In Brief: FDA 510(k) exemptions
This article was originally published in The Gray Sheet
Executive Summary
FDA 510(k) exemptions: Regulation takes effect Feb. 15, making 122 categories of devices Class I and exempting them from premarket notification requirements. The final rule downclassifying and exempting 111 devices and exempting 11 Class I devices was published in the Jan. 15 Federal Register ("The Gray Sheet" Jan. 22, p. 6)...