> 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/td11-pre-determined-changes.md).

# TD11 - Pre Determined Changes

As part of the technical documentation requirements, where applicable, any post-market pre-determined changes in the AI system and performance must be recorded. This check is mainly related to the post-market state of the AI system.