Overview
FDA is seeking innovative medical devices intended for use in the home or community setting that have the potential to improve post-acute care and reduce hospital readmissions. Organizations encouraged to participate include: Startup companies, Academic and research institutions, Healthcare facilities and health systems, Professional societies, Foundations and nonprofit organizations.
Selected participants will receive enhanced engagement with FDA through early regulatory feedback, sprint discussions, opportunities to demonstrate their technology, and other interactions designed to accelerate development. Please note this is a regulatory engagement opportunity rather than a funding opportunity.
September 30, 2026 – Phase 1 submission deadline (FDA notes that selections may begin before the deadline, so early submission is encouraged).
December 4, 2026 – Participants selected for the FDA Interaction Phase will be notified no later than this date.