FDA SaMD 510(k)/De Novo.
Buyer translation: this reference page maps the mark to a tool, system, control, deployment, or evidence question. clearance pathway for AI/ML device software functions · FDA SaMD 510(k)/De Novo governs AI that touches patients, ePHI, or coverage decisions. The duty is specific — transparency of a decision-support input, a change-control plan, a non-discrimination guarantee. Planisphere binds the duty to a measurement the evidence record can re-prove on the regulator's hardware.
Reviewed 2026-07-02
Prepare evidence for FDA SaMD 510(k)/De Novo reviewWhat this is.
Use. clearance pathway for AI/ML device software functions.
Source. petri dish · brass clearance stamp.
Register. 09 · Compliance controls — one of the ten registers of the PLANiSPHERE corpus library.
See it work.
Planisphere measures your tool deployment against FDA SaMD 510(k)/De Novo and seals the result into a signed, Merkle-rooted evidence record. The grade recomputes on your own hardware; the model state never crosses the boundary.
Promise. compliance
FDA SaMD 510(k)/De Novo governs AI that touches patients, ePHI, or coverage decisions. The duty is specific — transparency of a decision-support input, a change-control plan, a non-discrimination guarantee. Planisphere binds the duty to a measurement the evidence record can re-prove on the regulator's hardware.
Answers: How does Planisphere evidence FDA SaMD 510(k)/De Novo for a clinical AI?
Questions this answers.
The board that carries this.
FDA SaMD 510(k)/De Novo (clearance pathway for AI/ML device software functions) asks for an evidence record: FDA SaMD 510(k)/De Novo governs AI that touches patients, ePHI, or coverage decisions. The clinical AI workflow produces that record — see how it runs at /medicine.
CMS reg 09 · Medicare/Medicaid coverage · algorithm cannot be the sole basis to deny care DSI Source Attributes reg 09 · the 31 predictive-DSI source attributes as an evidence checklist FDA PCCP reg 09 · Predetermined Change Control Plan · drift-bounded model updates FDA PCCP / SaMD reg 09 · Predetermined Change Control · medical AI FSMB AI / state boards reg 09 · physician-responsibility · standard-of-care · state medical-board AI policySibling marks. Compliance controls
For each vertical.
FDA SaMD 510(k)/De Novo for defense AI workflow
NIST AI RMF · DoW RAI · OMB M-25-21 Open the pageFDA SaMD 510(k)/De Novo for clinical AI workflow
HHS §1557 · HIPAA · FDA PCCP Open the pageFDA SaMD 510(k)/De Novo for legal AI workflow
FRE 702 · ABA Model Rules Open the pageFDA SaMD 510(k)/De Novo for tutor and grader workflow
Title VI · FERPA · §504 / IDEA Open the pagePrepare evidence for FDA SaMD 510(k)/De Novo review.
First evidence record within 21 days of access · re-runs in a single business day.