FDA READI-Home Innovation Challenge for Medical Device Technologies

April 15, 2026

FDA Launches Home Innovation Challenge for Medical Device Technologies

James Boiani Epstein Becker & Green + Follow Contact LinkedIn Facebook X Send Embed

The Food and Drug Administration (FDA) is urging innovators, providers, and patients to “reimagine the home as an integral part of the health care system.”

If you’re skeptical, the “Home as a Health Care Hub” initiative was introduced in 2024 by the FDA’s Center for Devices and Radiological Health (CDRH) in response to changing needs of health care and feedback from the public, accelerated by the COVID-19 pandemic.

For investors and stakeholders, the “Home as a Health Care Hub” initiative focuses on advancing innovative medical devices used in the home to support health care. To that end, the FDA launched, on April 7, 2026, the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge (the “Challenge”).

The Challenge asks innovators to explore medical device technologies used in the home that support patients and caregivers after an acute hospital stay and that help prevent readmissions.

“Research…suggests there is interest in delivering hospital care outside the hospital setting,” FDA states. “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[.] The READI-Home Innovation Challenge builds on this clear interest in home-based care.”

Selection Criteria

Submissions to the Challenge 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 then consider whether:

• 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 is in a patient’s home and/or community environment (for the purposes of the 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 reduction in or prevention of readmission(s) for the target population(s); and

• Sufficient evidence exists to support the feasibility of the device under consideration.
  The FDA will also consider the clinical challenge the device is intended to address; the novelty of the device/concept; the current development status of the device; any data development plan (DDP) for the device; an overview of key expertise within the device development team; and the anticipated impact, 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.

Takeaways

Stakeholders should note that the submission period runs from April 7 to September 30, 2026. Up to nine (9) participants will be selected for an interaction phase beginning December 5, 2026. Participants should provide an executive summary and submission purpose as described in the “How to Submit” section of the notice.

Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.

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