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FDA READI-Home Innovation Challenge: Reducing Readmissions through Device Innovation for the Home

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Goals of the Innovation Challenge

The Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge aims to accelerate patient access to medical device technologies aimed at reducing hospital readmission.

As part of the FDA’s Center for Devices and Radiological Health’s (CDRH) Home as a Health Care Hub Initiative, the FDA invites innovators 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. 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.[1] Among patients without chronic conditions, the 30-day readmission rate was 13.9% between 2016 and 2020,[2] 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.[3,4]

Research also suggests there is interest in delivering hospital care outside the hospital setting. For example, a 2024 study in the Journal of the American Medical Association (JAMA) found that 47.2% of surveyed U.S. adults said hospital-at-home care would be acceptable, with similar preferences across age groups.[5] The READI-Home Innovation Challenge builds on this clear interest in home-based care.

The FDA encourages innovators who would benefit from early engagement with the agency to consider participation in the Innovation Challenge.

Timeline and 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 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. 

Selection of Challenge Participants

To be considered for the READI-Home Innovation Challenge, the innovation should meet the definition of a “device” in section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).[6] The FDA will consider the following elements to prioritize devices for potential participation in the Challenge:

  1. 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.
  2. At least one intended user is a patient and/or caregiver, as opposed to the device only being used by a trained medical professional.  
  3.  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.  
  4. Sufficient evidence (e.g., literature, data) exists to support that the device may be associated with reduction in or prevention of readmission(s) for the target population(s). 
  5. Sufficient evidence exists to support the feasibility of the device under consideration.

The FDA anticipates selecting up to nine (9) 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.

The FDA will also consider the following information:

a) Description of the device and the clinical challenge it is intended to address

  • Provide an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device.
  • Include information to support the potential for clinical success and the potential for clinically meaningful impact to the target population of interest.

b)    Novelty of the device/concept

  • Discuss whether the device represents a novel technology or novel application of an existing technology that has the potential to lead to a clinical improvement in the diagnosis, treatment (including monitoring of treatment), cure, mitigation, or prevention of a disease or condition. 
  • Discuss whether the device, when compared to existing approved or cleared alternatives, has the potential to help reduce or eliminate the need for readmission, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies following an acute hospital stay.
  • Discuss whether the device incorporates an innovative technological feature or represents an innovative use of a technology to accomplish a significant safety improvement.

c)    Current development status of the device

  • Provide a summary of the device's development status, including a list of all relevant previous communications with the FDA (if any) about the device.

d)    Data Development Plan (DDP) for the device

  • Provide information on the DDP for both clinical and non-clinical testing approaches completed and planned (Please refer to Appendix 2 of the Breakthrough Devices guidance for suggestions on content within a DDP). 
  • Identify specific challenges related to non-clinical and/or clinical testing.

e)    Overview of key expertise within the team

  • Provide the names of essential team members involved in device development and evaluation and their prior experience and/or expertise relevant to development of the device.

f)    Anticipated impact

  • Discuss how the device is expected to significantly improve the benefit-risk profile of a treatment or diagnostic compared to alternatives for the identified disease or condition, including whether the device is expected to result in one or more of the following:
    • a reduction in the occurrence of a known serious adverse event, 
    • a reduction in the occurrence of a known device failure mode,
    • a reduction in the occurrence of a known use-related hazard or use error, or
    • an improvement in the safety of another device or intervention

How to Submit

Please provide an executive summary (limited to 1 page) that summarizes how your device meets elements 1-5 followed by the information described in (a)-(f) above. Please limit this submitted information to 16 total pages (excluding references). Submitters should clearly identify any trade secret or confidential commercial information. All content should be written in English and converted to PDF format with Times New Roman font no smaller than 11-point. Prior to September 30, 2026, please submit your PDF as an Informational Q-submission through the CDRH portal with the following information in the relevant sections:

Company Name: Prefix with “READI-Home Innovation Challenge” (e.g., READI-Home Innovation Challenge – DeviceCompanyName).

Submission purpose: Include the following text: “This informational Q-submission provides information related to a medical device innovation intended to reduce or eliminate hospital readmission following post-acute hospital stays, consistent with the goal of the READI-Home Innovation Challenge. I understand this Q-submission will be reviewed by relevant CDRH staff for potential Breakthrough Devices (BTD) designation or Safer Technologies Program (STeP) designation as described for the Innovation Challenge, and may or may not result in a face-to-face meeting with the FDA. Regardless of the outcome of this review, I understand that I may still submit subsequent Q-submissions related to this medical device innovation. If my device is selected for the interaction phase of the READI-Home Innovation Challenge, I understand and agree that FDA will publicly disclose this participation in the Innovation Challenge, including the name and a description of my device and the name of the submitting company/organization, and I am duly authorized to agree to such disclosure.”

Contact Us

If you have questions about this Innovation Challenge, please email HealthHomeHub@fda.hhs.gov with the subject line “READI-Home Innovation Challenge Inquiry.”

[1] Reasons for readmission after hospital discharge in patients with chronic diseases—Information from an international dataset - PMC (Table 3)

[2] Characteristics Of 30-Day All-Cause Hospital Readmissions, 2016-2020

[3] Causes and correlates of 30 day and 180 day readmission following discharge from a Medicine for the Elderly Rehabilitation unit - PMC

[4] Journal of Family Medicine and Primary Care

[5] Acceptability of Hospital-at-Home Care and Capacity for Caregiver Burden | Health Care Delivery Models | JAMA | JAMA Network

[6] Under section 201(h)(1) of the FD&C Act, a device is defined as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”  The term “device” does not include a software function excluded from the device definition pursuant to section 520(o) of the FD&C Act. 

  

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