> For the complete documentation index, see [llms.txt](https://documentations.seclea.com/fda-ai-based-samd/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://documentations.seclea.com/fda-ai-based-samd/technical-documentation-td/td14-monitoring-function-and-control.md).

# TD14 - Monitoring, Function and Control

For compliance, a document that detailed information about the monitoring, functioning and control of the AI system, in particular concerning its capabilities and limitations in performance, including the degrees of accuracy for specific persons or groups of persons on which the system is intended to be used and the overall expected level of accuracy in relation to its intended purpose; the foreseeable unintended outcomes and sources of risks to health and safety, fundamental rights and discrimination gave the intended purpose of the AI system; the human oversight measures needed per [QMS](/fda-ai-based-samd/quality-management-principles-qmp.md) including the technical measures put in place to facilitate the interpretation of the outputs of AI systems by the users; specifications on input data, as appropriate.


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