FDA launches READI-Home Innovation Challenge focused on reducing hospital readmissions
The U.S. Food and Drug Administration (FDA) has announced the READI-Home Innovation Challenge, aimed at accelerating patient access to medical device technologies designed to reduce hospital readmissions.
The initiative is part of the FDA’s Center for Devices and Radiological Health (CDRH) Home as a Health Care Hub Initiative, which focuses on supporting the use of medical devices in home settings.
Focus on home-use medical devices
The FDA is inviting innovators to submit proposals for medical device technologies intended for use in the home environment, including devices that support patients and caregivers following an acute hospital stay.
These technologies are expected to help prevent avoidable hospital readmissions, which remain a significant challenge. According to the FDA:
30-day readmission rates for patients with chronic conditions range from 2.8% to 18.4%
Patients without chronic conditions had a 13.9% readmission rate (2016–2020)
Readmissions cost approximately 12% more than the initial hospital stay
Timeline and process
The Innovation Challenge includes two main phases:
Selection phase
Submission period: 7 April – 30 September 2026
Selection period: 1 October – 4 December 2026
During this phase, devices submitted via an informational Q-submission may be considered for:
Breakthrough Device designation (BTD)
Safer Technologies Program (STeP)
Interaction phase
Begins: 5 December 2026
Participants selected for this phase will engage with the FDA through more frequent interactions and feedback, including discussions to refine device design and testing for home use.
Selection criteria
To be considered, devices must meet the definition of a medical device under Section 201(h)(1) of the FD&C Act.
The FDA will prioritise devices that:
Address an unmet or emerging healthcare need in the home
Are intended for patients and/or caregivers
Are designed for use in a home or community environment
Have supporting evidence indicating potential to reduce or prevent readmissions
Demonstrate feasibility
Up to nine devices from different manufacturers will be selected to advance to the interaction phase.
Submission requirements
Manufacturers must submit:
A 1-page executive summary
Supporting documentation (maximum 16 pages, excluding references)
Submissions must include:
Device description and clinical context
Information on novelty
Development status
Data Development Plan (DDP)
Team expertise
Anticipated impact
Submissions must be made as an informational Q-submission via the CDRH portal before 30 September 2026.
Read the full document below.
