Zdrowie i gospodarka · 23/04/2014

FDA Releases Draft Guidance on Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval

The Food and Drug Administration (FDA) has released a draft guidance document titled "Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval," which clarifies the agency's policy on balancing premarket and postmarket data collection during the review of premarket approval applications (PMA). The guidance aims to improve the predictability, consistency, transparency, and efficiency of the premarket process, ultimately enhancing patient access to safe and effective medical devices.