ARPA-H ADVOCATE: The First Bid for FDA-Authorized Autonomous Clinical AI and What It Means for Developers
September 9, 2026
Focus area
FDA submissions and pathways
Pathway strategy and submission support for medical devices and SaMD: Pre-Submissions, 510(k), De Novo, PCCPs and Breakthrough Device requests.
How we help
Classification and pathway
Device determination, product code and predicate research, and whether 510(k) or De Novo fits.
Pre-Submissions
Focused questions and study proposals that get useful FDA feedback before you commit to testing.
510(k) and De Novo
Planning, writing and eSTAR assembly, through FDA questions and additional information requests.
Breakthrough and PCCPs
Breakthrough Device requests and predetermined change control plans for planned device changes.
