Revision Level History (RLH)

The revision level history document is an important component of the SaMD risk management framework, as it helps to ensure that any changes made to the software are properly documented, reviewed, and approved. This is important from a regulatory perspective, as the FDA requires that changes made to SaMD be properly documented and reviewed to ensure that they do not introduce new risks or affect the safety and effectiveness of the software.

Controls related to this risk category are listed as below:

• RLH 01 - AI Maintainability Strategy

• RLH 02 - Measurable Continuous Improvements

• RLH 03 - Sustained Value Mechanism

• RLH 04 - AI Deactivation Mechanism