WASHINGTON, D.C. — The FDA has announced the launch of the READI-Home Innovation Challenge, a new initiative aimed at fast-tracking medical devices designed to reduce hospital readmissions by moving care into the home.
The challenge is a key part of the FDA’s “Home as a Health Care Hub” initiative. It seeks to empower patients and caregivers with technologies that support recovery following acute hospital stays, addressing a critical gap in the current healthcare system.
Hospital readmissions represent a significant burden, with 30-day rates for chronic conditions reaching as high as 18.4%. Notably, readmissions often cost 12% more than the initial stay. With nearly half of U.S. adults reporting that “hospital-at-home” care is an acceptable alternative, the FDA is looking to bridge the gap with innovative technology.
Timeline and Deadlines
The challenge will proceed in two distinct phases:
- Selection Phase (April 7 – Sept. 30, 2026): Innovators must submit their proposals through the CDRH portal.
- Selection Period: The FDA will review submissions between October and early December.
- Interaction Phase (Beginning Dec. 5, 2026): Up to nine selected participants will engage in “sprint” discussions with the FDA, receiving frequent feedback to refine their designs and testing. Selected companies will also have the opportunity to demonstrate their tech at FDA research facilities.
Eligibility and Submission
To be prioritized, devices must address an unmet healthcare need in the home and be designed for use by patients or lay caregivers.
Submissions must include:
- A description of the device and its clinical impact.
- Evidence of feasibility and potential to reduce readmissions.
- A Data Development Plan (DDP) for clinical and non-clinical testing.
- An executive summary (1 page) with a total submission limit of 16 pages.
Innovators are encouraged to submit their proposals as an Informational Q-submission via the CDRH portal by the September 30, 2026, deadline. For inquiries, the FDA has established a dedicated contact at HealthHomeHub@fda.hhs.gov.
