Private Health Journal

Glossary · Regulation

Predetermined Change Control Plan

PCCP · algorithm change protocol

Predetermined Change Control Plan

Regulatory

An agreed description of how a model may be modified after authorisation without a new submission, and how each change will be verified.

The mechanism that lets a learning system be updated lawfully instead of freezing it at the version that was approved.

Context

RelatedAI-enabled Medical Device, Model Drift, Post-Market Surveillance
SourceFDA, Marketing Submission Recommendations for a Predetermined Change Control Plan