> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Opens READI-Home Innovation Challenge
- URL: https://www.fdaweb.com/fda-opens-readi-home-innovation-challenge/
- Published: 2026-04-07T12:00:00.000Z
- Updated: 2026-09-14T13:36:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160942

FDA has opened the selection phase of its Reducing Readmissions through Device Innovation for the Home (READI-Home) innovation challenge, which is intended to accelerate patient access to medical device technologies aimed at reducing hospital readmissions. An agency [post](https://www.fda.gov/medical-devices/home-health-care-hub/fda-readi-home-innovation-challenge-reducing-readmissions-through-device-innovation-home?ref=fdaweb.com) invites innovators to pursue potential participation in the challenge by providing proposed solutions for medical device technologies to be used in homes. “These technologies would support patients and caregivers after an acute hospital stay and may help prevent avoidable readmissions,” the agency says.

Applications will be received until 9/30, and up to nine devices will be chosen between 10/1 and 12/4\. An interaction phase that starts 12/5 will give selected participants early engagement with FDA through “sprint” discussions, including more frequent interactions and feedback to help refine device design and/or relevant testing for home use indications, the post says. Interaction phase participants will also have the opportunity to demonstrate their technology at FDA research facilities.

The notice says FDA will consider these elements to prioritize devices for potential participation in the challenge:

- the device is intended to address an unmet or emerging healthcare need in the home where expanded availability would be in the best interest of patients;
- at least one intended user is a patient and/or caregiver, as opposed to the device only being used by a trained medical professional;
- at least one of the device’s intended use environments is in a patient’s home and/or community;
- sufficient evidence exists to support that the device may be associated with a reduction in or prevention of readmissions for the target population(s); and
- sufficient evidence exists to support the feasibility of the device under consideration.

FDA says it will also consider:

- a description of the device and the clinical challenge it is intended to address;
- novelty of the device/concept;
- current development status of the device;
- data development plan for the device;
- overview of key expertise within the team; and
- anticipated impact.