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

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