*Advancing Home as a Health Care Hub: Building Sustainable CDRH Capabilities for
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $3,000,000 to $7,000,000
- 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 procuring services to establish sustainable capabilities supporting medical technologies used in the home, with solicitation estimated for release on August 1, 2026, and award anticipated February 1, 2027. The effort spans five coordinated areas: comprehensive stakeholder analysis with external resources, a Home Use Training and Education Program to build CDRH expertise and industry baseline standards, improved access to real-world evidence on device performance in home settings, exploration of a Home-Ready Regulatory Framework to standardize home-use considerations and enable scalable regulatory review, and operational infrastructure to sustain these activities. This is a new requirement with no set-aside applied.
The estimated award value ranges from $3 million to $7 million for a coordinated two-year effort. Inquiries should be directed to cdhracquisitions@fda.hhs.gov.
Forecast text
This investment would establish sustainable CDRH capabilities to support the increasing number, connectivity, and complexity of medical technologies used in the home. This FY27 investment would initiate a coordinated two-year effort across five mutually reinforcing area: (1) a comprehensive analysis of stakeholder insights resulting in external resources 2) a comprehensive Home Use Training and Education Program to build CDRH expertise and establish a common baseline for industry; (3) improved access to real-world evidence on device performance and challenges in the home; (4) exploration of a Home-Ready Regulatory Framework to standardize common home-use considerations and support more scalable regulatory review; and (5) operational infrastructure and support to sustain these and broader HHH activities.
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