Ani Biome PBC (Bruno Balen)

Docket FDA-2026-N-7874
Comment on Considerations for the Regulation of Generative AI-Enabled Medical Devices
Submitted by Ani Biome PBC

Ani Biome PBC welcomes FDA’s discussion of generative-AI-enabled medical devices. We support treating an update to an underlying foundation model as a controlled change. Developers should qualify each new model version against prespecified acceptance criteria before clinical use, with the intended use and risk controls unchanged. Evaluation should address the performance of the complete device in its intended setting.

We recommend that FDA recognize architectures in which a language model operates within a deterministic control layer that enforces permitted actions, requires clinician authorization before medical changes, and preserves an auditable record. These controls should be evaluated through observable performance in realistic clinical workflows.

We encourage FDA to clarify when bounded model-version changes may be included in an FDA-authorized Predetermined Change Control Plan (PCCP). Updates covered by and implemented consistently with that authorized PCCP could proceed without an additional marketing submission, according to the plan’s authorized scope and supporting evidence.

For agentic functions, we recommend defining competencies through observable, testable behaviors, including staying within protocol limits, obtaining required authorization, escalating appropriately, and declining unsupported claims. Testing should assess these behaviors across realistic multi-step interactions, with acceptance criteria proportionate to the intended use and consequences of error.

Bruno Balen
Ani Biome PBC