Register 09 · Compliance controls

FDA PCCP / SaMD.

FDA PCCP / SaMD can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decisions. A team can use Planisphere's self-serve API to gate actions and retain a measurement record for internal or external compliance review; Planisphere does not certify compliance, perform the HIPAA risk analysis, or replace the safeguard system of record.

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register 09 · Compliance controls· Healthcare regulation

Reviewed 2026-07-08

01 ·

What this is.

Seventy-two regulatory cite-anchors, organized for evidence lookup and review

Use. Predetermined Change Control · medical AI.

Register. 09 · Compliance controls — one of the 17 registers of the PLANiSPHERE corpus library.

02 ·

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. A team can use Planisphere's self-serve API to gate actions and retain a measurement record for internal or external compliance review; Planisphere 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?

03 ·

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
04 ·

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. Read the related clinical AI workflow product context 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
05 ·

Routes here from.

Where this mark is referenced in the Planisphere surface.
Defense Education Law Medicine About

Any internal link in the Planisphere site that names "FDA PCCP / SaMD" canonicalises here.

06 ·

Sibling marks. Compliance controls

Same register · same construction.
NIST AI RMF
NIST AI 100-1 · Govern · Map · Measure · Manage
OMB M-25-21/22
federal AI risk-management + acquisition
DoW RAI S&IP
Responsible · Equitable · Traceable · Reliable · Governable
EO 14179
Removing Barriers to American Leadership in AI (Jan 2025)
ISO/IEC 42001
international AI management system standard
FIPS 140-3
crypto module validation · 4 security levels
SHA-256 / FIPS 180-4
hash algorithm · per-file pinning primitive
SLSA v1.0
supply-chain levels for software artifacts
SBOM
software bill of materials · NTIA + CISA
SCITT
supply-chain integrity, transparency, trust · IETF
C-SCRM
supply-chain risk · NIST SP 800-161r1
07 ·

For each vertical.

FDA PCCP / SaMD framed for the four buyer surfaces.
For Defense

FDA PCCP / SaMD for defense AI workflow

NIST AI RMF · DoW RAI · OMB M-25-21 Open the page
For Medicine

FDA PCCP / SaMD for clinical AI workflow

HHS §1557 · HIPAA · FDA PCCP Open the page
For Law

FDA PCCP / SaMD for legal AI workflow

FRE 702 · ABA Model Rules Open the page
For Education

FDA PCCP / SaMD for tutor and grader workflow

Title VI · FERPA · §504 / IDEA Open the page

See the record FDA PCCP / SaMD asks for.

The console shows the evidence; the docs show the endpoints; the briefing shows what the product does and does not claim.

Open the Console Read the Docs Read the capability briefing
API ·

When FDA PCCP / SaMD asks for proof, hand over records — not assurances.

record the duty · seal the receipt · verify offline

Planisphere records each duty event — an output marked, a disclosure shown, a review made — and seals it into a receipt that verifies offline against our published keys. You send hashes, never content. A record is evidence a third party can check; it is not a certification and not a legal determination.

Open the Console Read the Docs Read the capability briefing

See how a record is checked