*Advancing Home as a Health Care Hub: Building Sustainable CDRH Capabilities for

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.

Estimated value

>= $3M and < $7M

Est. solicitation date

Aug 1, 2026

Anticipated award

Feb 1, 2027