LIST OF ABOUT 70 "RECOGNIZED" DEVICE STANDARDS, GUIDANCE DOCUMENT TO BE RELEASED BY FDA IN COMING WEEKS UNDER REFORM LAW; HIMA, NEMA SUPPORTIVE
This article was originally published in The Gray Sheet
Executive Summary
FDA plans to publish a list of about 70 "recognized" device standards and an accompanying guidance document in the next few weeks as it prepares to implement key provisions of the FDA Modernization Act.