FDA Device Center Launches READI-Home Challenge for Devices That Cut Readmissions

The Food and Drug Administration's device center has opened an innovation challenge for medical devices used at home that could help patients avoid going back to the hospital after an acute stay. The FDA's challenge page lists a submission period that began April 7 and runs through September 30.

The program is called the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge. It sits within the Center for Devices and Radiological Health's Home as a Health Care Hub initiative, which MedTech Dive reported started in 2024.

According to the FDA, the goal is "to accelerate patient access to medical device technologies aimed at reducing hospital readmission." The agency says the devices it is looking for would support patients and caregivers after an acute hospital stay.

What CDRH is looking for

The FDA lists five elements it will use to prioritize proposals. The device should address an unmet or emerging health care need in the home. At least one intended user should be a patient or caregiver rather than only a trained medical professional, and at least one intended use environment should be a home or community setting. The agency also wants evidence, such as literature or data, that the device may be associated with reducing or preventing readmissions, and evidence that the device is feasible.

Applicants submit through the CDRH portal as an informational Q-submission, with a one-page executive summary and no more than 16 pages in total, excluding references. The FDA asks for a description of the device, its novelty, its development status, a data development plan for clinical and non-clinical testing, the team's expertise and the anticipated impact on the benefit-risk profile compared with alternatives.

Devices described in a Q-submission during the selection phase may be considered for Breakthrough Device designation or Safer Technologies Program designation, as appropriate, the agency said.

Nine slots and a December deadline

The FDA said it anticipates selecting up to nine devices from distinct manufacturers. A manufacturer may submit information on several devices, but no more than one per company can advance. The selection period runs from October 1 to December 4, and the interaction phase begins December 5, according to the challenge page.

Participants that advance will receive "sprint" discussions with the agency, including more frequent interactions and feedback to help refine device design or testing for home use indications. They will also be able to demonstrate their technology at the FDA's research facilities, the agency said. MedTech Dive reported that the center plans to make its picks by December 4.

The FDA cited readmission figures to explain the focus. Thirty-day readmission rates for people with chronic conditions range from 2.8% to 18.4%, and among patients without chronic conditions the 30-day rate was 13.9% between 2016 and 2020, with readmissions costing about 12% more than the initial hospital stay, the agency said. It also pointed to a 2024 JAMA study in which 47.2% of surveyed U.S. adults said hospital-at-home care would be acceptable.

Questions about the challenge go to the Home as a Health Care Hub team at HealthHomeHub@fda.hhs.gov, according to the FDA.