FDA launches READI-Home innovation challenge for home-use medical devices

The FDA has launched the READI-Home Innovation Challenge, a program that seeks medical device concepts designed for use in the home and aimed at reducing avoidable hospital readmissions after an acute stay.

The agency said the selection-phase submission window opens April 7, 2026, and runs through September 30, 2026. FDA said it may choose up to nine devices from distinct manufacturers for an interaction phase beginning December 5, 2026.

According to the FDA, selected participants could receive early engagement with the agency, including sprint discussions and demonstrations at FDA research facilities. The challenge is part of FDA’s broader Home as a Health Care Hub initiative.

The agency’s CDRH updates page also lists the READI-Home challenge as an April 7 update, confirming the launch date.

The program is aimed at device makers developing home-care tools that could help patients recover safely outside the hospital and reduce preventable readmissions. FDA did not announce winners at launch; instead, it opened the application process and laid out the timeline for review and selection.

The challenge is another sign that the agency is encouraging device innovation for care delivery beyond the hospital setting.