Premarket-Postmarket Data Collection On FDA's Device Guidance Agenda

FDA has pegged as “A-list” priorities 12 device guidance documents it hopes to finalize this year that include guidances on balancing premarket and postmarket data collection for devices subject to premarket approval; and on crafting 510(k) submissions for devices that include antimicrobial agents. FDA last week issued its list of of final guidance documents it plans to develop in 2015, with the intention of clarifying or assuaging industry concerns on hot-button issues left over from 2014. FDA's Center for Devices...