FDA Launches READI-Home Challenge to Reduce Hospital Readmissions

HME Products

WASHINGTON—The U.S. Food & Drug Administration (FDA) is aiming to accelerate patient access to medical device technologies that reduce hospital readmission through the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge.

As part of the FDA’s Center for Devices and Radiological Health’s (CDRH) Home as a Health Care Hub Initiative, the FDA said it is inviting inventors to pursue potential participation in the innovation challenge by providing proposed solutions for medical device technologies to be used in the home setting. These technologies would support patients and caregivers after an acute hospital stay and may help prevent avoidable readmissions.

“Hospital readmissions create significant personal, financial and logistical challenges for patients, caregivers and the health care system,” the FDA said in a release. “Thirty-day readmission rates for people with chronic conditions range from 2.8% to 18.4%, and more than half of these readmissions occur for reasons different from the original hospitalization. Among patients without chronic conditions, the 30-day readmission rate was 13.9% between 2016 and 2020, with readmissions costing about 12% more than the initial hospital stay. These trends highlight the need for innovative medical devices that support patient-centered care and reduce readmissions.”

The FDA said it encourages innovators who would benefit from early engagement with the agency to consider participation in the innovation challenge.

To be considered for the READI-Home Innovation Challenge, the invention should meet the definition of a “device” in section 201(h)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act). The FDA will consider the following elements to prioritize devices for potential participation in the challenge:

  • The device is intended to address an unmet or emerging health care 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 intended use environments for the device is in a patient’s home and/or community environment. For the purposes of this challenge, the home environment includes, but is not limited to, an individual’s residence without the continuous presence of trained medical professionals.  
  • Sufficient evidence (e.g., literature, data) exists to support that the device may be associated with a reduction in or prevention of readmission(s) for the target population(s). 
  • Sufficient evidence exists to support the feasibility of the device under consideration. 

The FDA said it anticipates selecting up to nine devices from distinct manufacturers to move on to the interaction phase. While a manufacturer may submit information regarding multiple devices, no more than one device per manufacturer may advance to the interaction phase.

Timeline & Deadlines

The READI-Home Innovation Challenge includes two phases:

Selection phase:

  • Submission period: April 7, 2026 – September 30, 2026
  • Selection period: October 1, 2026 – December 4, 2026

Devices described in an informational Q-submission to the FDA during the selection phase may be considered for Breakthrough Device (BTD) designation or Safer Technologies Program (STeP) designation, as appropriate. The FDA said it will consider the factors and information described below to determine which devices will move forward to the interaction phase of the innovation challenge. The FDA intends to notify participants selected for the interaction phase by December 4, 2026.

Interaction phase:

  • Phase begins: December 5, 2026

Participants selected to advance to the interaction phase of the innovation challenge will receive valuable early engagement with the FDA through “sprint” discussions, including more frequent interactions and feedback to help refine device design and/or relevant testing for home use indications. Participants in the interaction phase will also have the opportunity to demonstrate their technology at the FDA’s research facilities. The FDA also intends to announce the company/organization advancing to the interaction phase on the FDA’s public-facing webpage. 

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