*Digital Health Real-World Performance Observatory Postmarket Governance Pilot
Forecast New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $1,500,000 to $3,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- Points of contact
-
- CDRH Acquisition Liaison cdhracquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is conducting a pilot to design and implement a federated observatory model for monitoring real-world performance of digital health medical devices after market deployment, with solicitation estimated for January 1, 2027 and award targeted for August 1, 2027. The pilot will establish FDA's postmarket oversight capability as part of a three-component program addressing premarket review, evaluation science, and postmarket surveillance of digital health devices. The federated approach will draw on participating health systems, manufacturers, professional societies, data partners, and federal partners to identify performance degradation, distribution shift, subgroup performance changes, workflow-related failures, update-related changes, and other safety signals.
The estimated award value ranges from $1.5 million to $3 million. Inquiries should be directed to the FDA's Center for Devices and Radiological Health Acquisitions mailbox at cdhracquisitions@fda.hhs.gov.
Forecast text
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.
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