NEMA SEEKING 510(K) EXEMPTION OF 17 ADDITIONAL RADIOLOGY DEVICES
This article was originally published in The Gray Sheet
Executive Summary
NEMA SEEKING 510(K) EXEMPTION OF 17 ADDITIONAL RADIOLOGY DEVICES, according to Oct. 12 comments on FDA's proposed regulation to exempt certain Class I, Tier I devices from premarket notification requirements. In its July 21 proposed 510(k) exemption of Class I, Tier I devices, FDA identified four Class I radiology products ("The Gray Sheet" July 25, p. 4).