*Digital Health Real-World Performance Observatory Postmarket Governance Pilot

This is one of three complementary proposals designed to build FDA's end-to-end capability for regulatory review of new digital health medical devices across (1) premarket review, (2) evaluation science, and (3) postmarket oversight. design and pilot a national-scale approach for monitoring the real-world performance of digital health medical devices after deployment. Rather than creating a single centralized FDA database, the investment would test a federated observatory model that can draw on participating health systems, manufacturers, professional societies, data partners, and relevant federal partners to identify performance degradation, distribution shift, subgroup performance changes, workflow-related failures, update-related changes, and other safety signals.

Estimated value

>= $1.5M and < $3M

Est. solicitation date

Jan 1, 2027

Anticipated award

Aug 1, 2027