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Does my AI feature need FDA 510(k) or De Novo clearance?

If your AI feature meets the definition of a medical device (Software as a Medical Device) — intended to diagnose, treat, or inform clinical decisions in a way that makes it a device function — it generally needs clearance: a 510(k) if a predicate exists, or…

register 09 · Compliance pins· FDA SaMD 510(k)/De Novo
01 ·

Answer.

Healthcare regulation · FDA SaMD 510(k)/De Novo.

If your AI feature meets the definition of a medical device (Software as a Medical Device) — intended to diagnose, treat, or inform clinical decisions in a way that makes it a device function — it generally needs clearance: a 510(k) if a predicate exists, or De Novo for a novel low-to-moderate-risk type with no predicate. Pure administrative or wellness features often fall outside. The device determination is FDA's; Planisphere supplies model-behaviour evidence for whichever pathway applies, it does not decide your regulatory status.

02 ·

The mark behind the answer.

FDA SaMD 510(k)/De Novo can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impa…

clearance pathway for AI/ML device software functions.

→ Full reference for FDA SaMD 510(k)/De Novo

Prepare evidence for FDA SaMD 510(k)/De Novo review.

First evidence record within 21 days of access · re-runs in a single business day. Planisphere measures model behaviour and emits a reproducible, sha-pinned record — it does not certify, file, or give legal advice.

Scope an AI workflow review Prepare evidence for clinical AI review FDA SaMD 510(k)/De Novo reference