What goes in an FDA Predetermined Change Control Plan (PCCP)?
A PCCP describes, in advance, the modifications you intend to make to an AI/ML device function, how you will implement them (the modification protocol), and the impact assessment showing the device stays safe and effective within those bounds — letting you…
Answer.
A PCCP describes, in advance, the modifications you intend to make to an AI/ML device function, how you will implement them (the modification protocol), and the impact assessment showing the device stays safe and effective within those bounds — letting you update the model without a new marketing submission for changes inside the plan. The key is pre-specified, bounded change with monitoring. Planisphere's drift evidence shows whether the model stayed inside its declared bounds; it does not author or clear the PCCP.
The mark behind the answer.
Predetermined Change Control Plan · drift-bounded model updates.
More on FDA PCCP.
Prepare evidence for FDA PCCP review.
First evidence record within 21 days of access · re-runs in a single business day. Planisphere measures model behaviour and emits a reproducible, sha-pinned record — it does not certify, file, or give legal advice.