GMP design control enforcement to be discussed at FDA public meeting Sept. 12.
This article was originally published in The Gray Sheet
Executive Summary
DEVICE DESIGN CONTROLS: FDA PUBLIC MEETING ON ENFORCEMENT STRATEGIES is scheduled for Sept. 12, the agency says in an Aug. 30 Federal Register notice. FDA is calling the meeting to solicit comments from the medical device industry and other interested parties "about their perspective and practical experience in exercising design controls." The meeting will run from 8:30 a.m. to 4:30 p.m. at FDA's Parklawn Building, 5600 Fishers Lane, Rockville, Maryland.