Business · 29/04/2015Updated: 10/17/2026 · 1 min read

FDA Review of Premarket Approval Applications for Medical Devices: Balancing Pre- and Postmarket Data Collection

The FDA is reviewing the progress of its 2014-2015 Strategic Priority to strike a balance between premarket and postmarket data collection for high-risk medical devices, aiming to expedite development and review by December 31, 2014, for 50% of product codes subject to premarket approval applications.