1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Home Health and Consumer Devices
  5. Home as a Health Care Hub
  6. READI-Home Innovation Challenge Frequently Asked Questions
  1. Home as a Health Care Hub

READI-Home Innovation Challenge Frequently Asked Questions

The FDA announced a new Innovation Challenge titled, “READI-Home: Reducing Readmissions through Device Innovation for the Home.” The goal of this Innovation Challenge, which is part of the FDA’s Home as a Health Care Hub Initiative, is to accelerate patient access to medical device technologies aimed at reducing hospital readmission. Innovation in this area has the potential to reduce morbidity and mortality associated with chronic conditions and significantly reduce the financial and logistical burden on the healthcare system.

Frequently Asked Questions (FAQs)

The frequently asked questions (FAQs) below are intended to help innovators find answers to commonly asked questions about the READI-Home Innovation Challenge. For other questions, please email HealthHomeHub@fda.hhs.gov.

Eligibility and Scope

1. Are medical devices with existing market authorizations eligible for this Challenge?

The Challenge is not intended for medical devices with existing marketing authorization where no modifications or changes to the device or its intended use are being proposed. Medical devices with existing marketing authorization that are proposed to be changed or modified may be considered, and like other devices, may be prioritized for potential participation in the Challenge where the device (as changed or modified) aligns with the five prioritization elements listed in the Selection of Challenge Participants section of the webpage. Submitters should describe how the device, as changed or modified, would meet these elements.

2. Is Software as a Medical Device in scope for this Challenge?

It may be in scope. 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). The FDA will consider the five prioritization elements listed in the Selection of Challenge Participants section of the webpage.

3. Are pediatric devices in scope for this Challenge?

Devices intended for pediatric populations may be within the scope of the READI-Home Innovation Challenge. Participants are encouraged to review the factors and information on the webpage that will be considered during review of the proposed medical device innovations.

4. Are there particular diseases and/or conditions that will be the focus of this challenge?

The challenge is open to devices for any disease or condition. The READI-Home Innovation Challenge invites innovators to provide 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.

The FDA intends to prioritize devices for potential participation in the Challenge where, among other things, sufficient evidence (for example literature and/or data) exists to support that the device may be associated with reduction in or prevention of readmission(s) for the target population(s).

Submission

5. Is there a specific template for the submission?

There is no template for the information to be provided in the informational Q-submission. However, participants are encouraged to use the structure of the factors and information that will be considered during review of the innovations when preparing their submission.

Selection

6. How will FDA evaluate and select participants?

Upon receipt of an informational Q-submission, the FDA will consider the five prioritization elements and six factors listed in the “Selection of Challenge Participants” section of the webpage. The FDA anticipates selecting up to nine devices from distinct manufacturers to move on to the interaction phase.

7. When will the FDA begin selecting participants?

The FDA may select devices to advance to the interaction phase prior to closure of the submission period on September 30, 2026. The FDA intends to notify up to nine selected participants no later than December 4, 2026.

8. When does the interaction phase begin?

A participant or company enters into the interaction phase immediately following notification of their device selection. An FDA staff member assigned to their informational Q-submission will reach out to the listed point of contact to discuss next steps.

Other

9. Is there funding provided for challenge participants?

No, this challenge does not provide funding, grants, or monetary awards to participants.

Back to Top