FDA PCCP.
FDA's final guidance on Predetermined Change Control Plans (2024-12-03) lets a sponsor pre-specify, in a marketing submission, how an AI-enabled device software function may change after authorization without a new submission. The evidence record proves: Drift — re-runs measure whether the updated model has moved off its authorized baseline, sizing each change against the Modification Protocol
Reviewed 2026-07-08
What this is.
Use. Predetermined Change Control Plan · drift-bounded model updates.
Register. 09 · Compliance controls — one of the 17 registers of the PLANiSPHERE corpus library.
Promise. compliance
FDA PCCP 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 review?
See it work.
Planisphere measures your tool deployment against FDA PCCP 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.
What it requires.
FDA's final guidance on Predetermined Change Control Plans (2024-12-03) lets a sponsor pre-specify, in a marketing submission, how an AI-enabled device software function may change after authorization without a new submission. The final scope covers all AI-DSF (the draft was ML-only) and requires three components: a Description of Modifications, a Modification Protocol, and an Impact Assessment. The obligation is to bound and document model change in advance and to show that post-authorization updates stay inside the pre-approved envelope.
What the evidence record proves.
- Drift — re-runs measure whether the updated model has moved off its authorized baseline, sizing each change against the Modification Protocol
- Distinctness — outputs remain separable across the cohorts the device was validated against after a modification
- Coherence — the modified model's output is still consistent with its intended use
- Each measured row carries its cite-anchor and a SHA, sealed in a Merkle-rooted, reproducible record
- Provides the empirical change-control record a PCCP Impact Assessment runs on
What this does not prove. Planisphere does not clear or authorize a device, does not file with FDA, and does not decide whether a modification stays within or exceeds the PCCP — that determination is FDA's and the sponsor's. It measures model behaviour to evidence the change-control record; it is not a regulatory submission and not legal advice.
Questions this answers.
The board that carries this.
FDA PCCP asks for an evidence record: FDA's final guidance on Predetermined Change Control Plans (2024-12-03) lets a sponsor pre-specify, in a marketing submission, how an AI-enabled device software function may… 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 / SaMD reg 09 · Predetermined Change Control · medical AISibling marks. Compliance controls
For each vertical.
FDA PCCP for defense AI workflow
NIST AI RMF · DoW RAI · OMB M-25-21 Open the pageFDA PCCP for clinical AI workflow
HHS §1557 · HIPAA · FDA PCCP Open the pageFDA PCCP for legal AI workflow
FRE 702 · ABA Model Rules Open the pageFDA PCCP for tutor and grader workflow
Title VI · FERPA · §504 / IDEA Open the pageSee the record FDA PCCP asks for.
The console shows the evidence; the docs show the endpoints; the briefing shows what the product does and does not claim.