Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval: Guidance for Industry and Food and Drug Administration Staff

Issue Date: April 13, 2015
Issued by: Center for Devices and Radiological Health
Topic(s): Postmarket, Premarket, Premarket Approval (PMA)
Status: Final

Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval: Guidance for Industry and Food and Drug Administration Staff

This 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 applications (PMAs). 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.

Download the Guidance Document