*Digital Health Real-World Performance Observatory Postmarket Governance Pilot

The Digital Health Real-World Performance Observatory Postmarket Governance Pilot is a Food and Drug Administration initiative aimed at establishing a national-scale framework for monitoring the performance of digital health medical devices after they have been deployed. As part of a broader three-pronged strategy to enhance regulatory review capabilities, this specific project focuses on postmarket oversight to ensure the ongoing safety and efficacy of digital health technologies. Instead of implementing a centralized database, the FDA intends to pilot a federated observatory model. This approach leverages a network of health systems, manufacturers, professional societies, and federal partners to detect critical safety signals, including performance degradation, distribution shifts, workflow failures, and issues arising from software updates or subgroup performance changes.