FDA Lays Out Inner Workings Of Device Advisory Panels In Draft Guidance

FDA Lays Out Inner Workings Of Device Advisory Panels In Draft Guidance-thegraysheet: CDRH explains how it consults with its device advisory panels, types of panel meetings, deadlines for participating firms in an April 1 draft guidance. The guidance comes following recent CDRH-industry discussions on the impact of the panel process on PMA decision times. It also states panel meetings may be considered for 510(k), de novos and HDEs.