COMPREHENSIVE COMPLIANCE REVIEWS PLANNED FOR THREE TO FOUR DEVICE CATEGORIES IN 1997 UNDER FDA "RISK-BASED" SURVEILLANCE INITIATIVE; PUBLIC MEETING PLANNED
This article was originally published in The Gray Sheet
Executive Summary
FDA is targeting three to four devices for intensive compliance scrutiny in the coming year out of a list of 15 devices designated as high priorities for action. The list was unveiled by Lillian Gill, director of the Office of Compliance in FDA's Center for Devices and Radiological Health, Dec. 10 at the Food and Drug Law Institute annual conference on Dec. 10 in Washington, D.C.