Authorized predetermined change control plan (Authorized PCCP)

Once authorized, the plan becomes part of the device itself. Changes that follow it can be made without a new submission, while changes outside it still need the usual route, so the plan has to be followed as written.

A PCCP that has been reviewed and established through a device marketing authorization. An authorized PCCP is a technological characteristic of the authorized device with which it was established.

FDA guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (August 2025), Section IV, Definitions