Impact assessment

The impact assessment is one of the three parts of a PCCP, together with the description of modifications and the modification protocol. It shows FDA that the planned changes were thought through before they are made.

The documentation of the assessment of the benefits and risks of implementing a PCCP, as well as the plan for risk mitigation.

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