How do I scope the FDA PCCP / SaMD audit?

Use the brass 'Prepare evidence for FDA PCCP / SaMD review' button. First evidence record within 21 days of access; re-runs in a single business day.

FDA PCCP / SaMD.

Prepare evidence for FDA PCCP / SaMD review

Buyer translation: this reference page maps the mark to a tool, system, control, deployment, or evidence question. Predetermined Change Control · medical AI · FDA PCCP / SaMD can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decisions. Planisphere maps the workflow, runs the harness, and packages the measurement record for internal or external compliance review; it does not certify compliance, perform the HIPAA risk analysis, or replace the safeguard system of record.

Reviewed 2026-07-02

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What this is.

Sixty-nine marks · cite-anchors for every regulatory regime Planisphere maps to · postmark idiom · single distinctive brass glyph per control · universal classifier · pSEO surface

Use. Predetermined Change Control · medical AI.

Source. envelope + brass clearance clock.

Register. 09 · Compliance controls — one of the ten registers of the PLANiSPHERE corpus library.

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Promise. compliance

The contract this mark binds — derived, not asserted.

FDA PCCP / SaMD can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decisions. Planisphere maps the workflow, runs the harness, and packages the measurement record for internal or external compliance review; it does not certify compliance, perform the HIPAA risk analysis, or replace the safeguard system of record.

Answers: What evidence can Planisphere prepare for FDA PCCP / SaMD review?

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See it work.

Evidence record you can check — not code you have to trust.

Planisphere measures your tool deployment against FDA PCCP / SaMD 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.

Prepare evidence for clinical AI review →See how a record is checked

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The board that carries this.

Related marks, and the surface this one funnels to.

FDA PCCP / SaMD (Predetermined Change Control · medical AI) asks for an evidence record: FDA PCCP / SaMD can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting 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

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