Key Takeaways
- The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) opened its READI-Home Innovation Challenge, offering up to nine device sponsors early, focused engagement on home-use devices that may help reduce hospital readmissions; submissions are due by September 30, 2026, with participants selected by December 4, 2026.
- Eligible devices must meet statutory device definition and satisfy five prioritization factors; only one device per manufacturer may advance to the interaction phase.
- Participation offers earlier FDA feedback and potential exposure to Breakthrough Devices Program and Safer Technologies Program (STeP) designations, but does not guarantee clearance or expedite formal review.
The FDA’s CDRH announced the Reducing Readmissions through Device Innovation for the Home Innovation Challenge (READI-Home Innovation Challenge, or Innovation Challenge), a program that offers selected device sponsors early and frequent engagement with the FDA on home-use medical devices, which face unique challenges given the diverse home environments where people live and use such devices. The submission window closes on September 30, 2026. The FDA intends to select up to nine participants no later than December 4, 2026, which will be publicly disclosed by the FDA.1 Companies that develop medical devices intended for use in home or community settings and that can reduce or prevent hospital readmissions may benefit from early engagement with the FDA to ensure a more successful submission and review process, including feedback on usability and performance testing involving patients and caregivers.
The Innovation Challenge sits inside a broader CDRH effort, the Home as a Health Care Hub initiative (Initiative), which the FDA launched in April 2024. Although related, this Initiative and the Innovation Challenge serve distinct functions and have different implications for sponsors. The Initiative reflects CDRH’s priorities for home-based care, and while it does not establish new legal requirements or alter existing marketing-authorization standards, it offers insight into how the FDA is thinking about home-use device development and evaluation. The Innovation Challenge, by contrast, is a specific engagement program with defined eligibility criteria, submission requirements, and timelines. Sponsors developing post-discharge technologies for use in the home can use the program to engage with the FDA earlier in the development process and receive focused feedback on home-use considerations.
Home as a Health Care Hub Initiative
The FDA launched this Initiative to advance its vision of the home as an integrated part of the healthcare delivery system rather than simply a setting in which individual devices are used.2 The Initiative reflects broader trends in healthcare delivery, including increasing demand for home-based care, workforce constraints, rising healthcare costs, and the growing prevalence of chronic disease.
One of the Initiative’s principal outputs is the Idea Lab, a collection of developer resources created in collaboration with the architecture firm HKS, Inc. A central component of the Idea Lab is Lilypad, a virtual-reality-based model of home environments, including a single-family home, mobile home, and apartment, which allows developers to evaluate how devices may perform in real-world residential settings. The FDA initially developed the platform around diabetes management in lower-resource housing environments, but the concepts are intended to be broadly applicable across a range of home-based care scenarios. Developers can download the Lilypad environment and incorporate their own devices into the simulations for usability assessment.3
A consistent theme across the Initiative is the importance of usability and comprehension by patients and lay caregivers. Through public meetings and stakeholder engagement, the FDA has emphasized the need for home-use devices to be understandable and usable outside traditional clinical settings. As a result, user comprehension, label comprehension, simulated-use testing, and self-selection studies remain important components of the FDA’s evaluation of devices intended for home use. For sponsors developing home-based technologies, these themes provide useful insight into the human factors and usability considerations that are likely to remain areas of regulatory focus.
The READI-Home Innovation Challenge
The Innovation Challenge is intended to support development of technologies that may help reduce hospital readmissions following an acute care episode, particularly devices designed for use by patients and caregivers in home and community settings, including for monitoring, treatment, and recovery outside traditional clinical environments.
Eligibility and Selection Criteria
To be eligible for the Innovation Challenge, a product must meet the statutory definition of a device under Section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and must not be excluded under Section 520(o).4 Additionally, the FDA has identified five factors for prioritizing devices for potential participation, including:
- whether the device addresses an unmet or emerging healthcare need in the home;
- whether patients and/or caregivers are among the intended users;
- whether the home and/or community setting is an intended use environment;
- whether sufficient evidence exists to support that the device may be associated with a reduction or prevention of readmissions; and
- whether sufficient evidence exists to support the feasibility of the device.5
While manufacturers may submit the required information via an informational Q-Submission on more than one device, only one device per manufacturer may advance to the interaction phase of the program if selected for participation.
Additional Considerations for Participation
The program is designed to provide earlier and more frequent engagement with the FDA than is typically available through the standard Pre-Submission process, with a particular focus on home-use issues such as usability, labeling for lay users, and performance in less controlled environments. Because the same submission may be reviewed for the Breakthrough Devices Program and Safer Technologies Program (STeP) designations, participation can also surface eligibility for those programs at no additional cost.6
Notably, participation does not alter the regulatory standard applicable to the submission pathway. Selection for participation in the program does not guarantee clearance, authorization, or approval, and it does not shorten the regulatory review of an eventual 510(k), De Novo, or premarket approval submission. The program is intended as an early engagement and feedback opportunity with the FDA, layered on top of the existing regulatory pathways. Of note, once selected, the FDA will publicly disclose the devices participating in the Innovation Challenge, including the name and description of the device and the name of the submitting company/organization. This public disclosure could compromise the company’s competitive advantage or intellectual property position if not considered carefully.
Sponsors considering participation should review the program requirements carefully and assess whether the opportunity for enhanced interaction with the FDA aligns with their broader FDA regulatory, intellectual property, and business strategies.
For additional information concerning FDA programs and regulatory strategies for medical devices, software as a medical device, and other health technologies and apps, please contact Wilson Sonsini attorneys Ty Kayam or Eva Yin of the firm's Healthcare and FDA Regulatory practice.
[1] FDA, “FDA READI-Home Innovation Challenge: Reducing Readmissions through Device Innovation for the Home,” fda.gov (accessed Apr. 7, 2026) (hereinafter “READI-Home Program Page”).
[2] Press Release, FDA, “FDA Launches Health Care at Home Initiative” (Apr. 23, 2024), fda.gov; FDA, “Home as a Health Care Hub,” fda.gov.
[3] Press Release, FDA, “CDRH Unveils Home as a Health Care Hub’s Idea Lab to Help Reimagine How New and Existing Medical Technologies Can Be Incorporated Into the Home” (Dec. 30, 2024), fda.gov; see also FDA, “Idea Lab,” fda.gov.
[5] READI-Home Program Page, supra note 1 (selection factors).
[6] READI-Home Program Page, supra note 1 (review for potential Breakthrough Devices Program and Safer Technologies Program designations).
