Modification protocol

The modification protocol is what allows FDA to accept changes made later without a new submission. It needs predefined acceptance criteria and verification and validation methods, and changes that do not follow it fall outside the authorized PCCP.

The documentation describing the methods that will be followed when developing, validating, and implementing modifications delineated in the Description of Modifications section of the PCCP. The Modification Protocol includes the verification and validation activities (including pre-defined acceptance criteria) for those modifications and is intended to provide a step-by-step delineation of how the modifications included in the PCCP will be implemented while ensuring the device remains safe and effective.

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