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.
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Predetermined Change Control Plan · drift-bounded model updates.
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