FDA DELEGATION OF DEVICE GMP, PREMARKET REVIEW ACTIVITIES TO OUTSIDE BODIES
This article was originally published in The Gray Sheet
Executive Summary
FDA DELEGATION OF DEVICE GMP, PREMARKET REVIEW ACTIVITIES TO OUTSIDE BODIES is under evaluation by upper-level staff at the Center for Devices and Radiological Health. Under a third-party certification program, FDA would contract with independent organizations to perform agency functions such as device good manufacturing practices inspections and/or review of premarket data.