Specialized Device Inspectorate Part Of Joint CDRH/ORA Action Plan
This article was originally published in The Silver Sheet
Executive Summary
FDA’s Office of Regulatory Affairs will establish a specialized unit of device-focused field investigators according to a 2015 CDRH/ORA program alignment action plan posted online Oct. 7. Under the announced steps, CDRH will work with ORA throughout the current fiscal year to develop a plan for establishing a medical device inspectorate and a separate mammography quality inspectorate.