CDRH Industry: Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Draft Guidance for Industry and FDA Staff

A draft guidance for Industry and U.S. Food and Drug Administration Staff about Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval has recently been posted. This draft guidance clarifies the Food and Drug Administration's (FDA or the Agency) current policy on balancing premarket and postmarket data collection during FDA review of premarket approval (PMA) applications. More specifically, this guidance outlines how FDA considers the role of postmarket information in determining the extent of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of reasonable assurance of safety and effectiveness.  For more information, please see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm393882.htm