Glossary · Regulation
PCCP
Predetermined Change Control Plan
A PCCP is a plan, authorised by the FDA as part of a device's marketing submission, that describes future changes to the device and how they will be tested and implemented.
Once authorised, changes such as retraining an AI model can be made without a new submission each time, provided the description of modifications, modification protocol and impact assessment are followed.
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Definitions written by Anpheros from the official sources linked on each page. General information about standards and regulation, not legal or medical advice. All terms →