Comment from Any Biosignal Inc.

Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Docket No. FDA-2026-N-4390, “AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information” Dear Deputy Chief Medical Officer Mundkur and FDA colleagues: Any Biosignal, Inc. (“AnyBio”) appreciates the opportunity to respond to FDA’s Request for Information on the proposed pilot program for AI-enabled optimization of early-phase clinical trials. AnyBio is vendor-neutral healthcare-data infrastructure for biosignal processing. We are not an algorithm developer, and we do not compete with the algorithm and model developers whose tools would participate in this pilot. We are the governed layer on which validated algorithms from any vendor can run on continuous biosignal data, with provenance and audit maintained from raw signal through reported endpoint, and from which results are delivered into clinical and trial systems in standard FHIR form. We submit this comment to make one central recommendation and to offer a perspective the question structure does not yet capture. The recommendation is that the pilot explicitly include continuous real-time biosignal monitoring and device-derived endpoints as eligible data sources. The perspective is that a vendor-neutral infrastructure layer, one not owned by a device manufacturer or a single algorithm developer, is what allows validated tools from multiple developers to be evaluated under uniform governance, provenance, and audit. The continuous-monitoring future the agency has described needs such a layer, and we believe that need is not yet well served by the vertically integrated platforms that lead continuous monitoring today. The comment is organized by RFI category and question number per FDA’s instructions. It opens with an Executive Summary carrying our recommendations, followed by responses to specific questions, four gaps the RFI does not directly address, and references. Respectfully submitted, Stephen R. Saine Founder and Chief Executive Officer Any Biosignal, Inc.