FDA Updates Device READI-Home Innovation Challenge Initiative

FDA has provided additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate development of medical devices intended to reduce avoidable hospital readmissions by supporting patients in home settings following discharge.

The challenge, formally known as READI-Home: Reducing Readmissions through Device Innovation for the Home, is part of the agency's broader Home as a Health Care Hub Initiative. FDA officials said the program is intended to encourage innovation in technologies that could improve post-hospital care, reduce complications associated with chronic disease, and ease financial and operational pressures on the healthcare system.

According to a newly released Frequently Asked Questions document, the challenge is open to a broad range of device technologies intended for home use following an acute hospital stay. FDA says the initiative is not limited to specific diseases or medical conditions. Instead, the agency is seeking devices that can help patients and caregivers manage care at home and potentially prevent avoidable readmissions.

The agency indicates that software-based products may be eligible if they meet the statutory definition of a medical device under the Federal Food, Drug, and Cosmetic Act. Pediatric devices are also eligible for consideration. While devices that already have FDA marketing authorization generally are not the focus of the challenge, the agency says products that are being modified or proposed for new intended uses may be considered if they align with the program's prioritization criteria.

FDA plans to evaluate submissions using five prioritization elements and six review factors outlined on the challenge Web site. Among other considerations, the agency says it will prioritize technologies supported by evidence suggesting they could reduce or prevent hospital readmissions in the intended patient population.

Companies participating in the challenge must submit information through an informational Q-submission. FDA noted that no specific submission template is required, although applicants are encouraged to organize their materials around the evaluation criteria described by the agency.

The agency anticipates selecting up to nine devices from different manufacturers to advance to an interaction phase that will provide participants with direct engagement opportunities with FDA staff.

Notably, FDA says it may begin selecting participants before the submission period closes on 9/30. The agency expects to notify selected companies no later than Dec. 4, 2026. Once selected, participants will immediately enter the interaction phase and be contacted by FDA personnel assigned to their submission to discuss next steps.