Document templates for the 22 Software and Cybersecurity related documents in for SaMD

[510ktemplates]

Hi I'm working on an innovation project where we have to simulate different parts of an eSTAR 510K submission.
I've chosen to focus on SaMD and have seen the 22 related documents in the software and cybersecurity sections.
I'm looking to find some templates for what the 22 documents involve so I can decide which ones to do / have some idea where to start.
I don't seem to be able to find templates anywhere (especially that are up to date for eSTAR) - just wondering if I can find them somewhere or if they are protected for some reason?
Thanks!

 

[yodon]

I can't rattle off the 22 documents required off the top of my head, but some can't be template-based. SBOMs, for example, are extracted from the code and output in .json or .xml (or similar) format. FDA is not prescriptive on HOW something is done; e.g., the cybersecurity risk analysis. There are many ways to accomplish this. Maybe if you search for specific document types you can find examples?