IDE submission - cybersecurity documents


Dear all,

In the guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff ", FDA requests the following documents :
· Inclusion of cybersecurity risks as part of Informed Consent Form (21 CFR 50.25(a)(2) and 21 CFR 812.25(g));
· Global, Multi-patient and Updateability/Patchability views (21 CFR 812.25(c), (d))
· Security Use case views for functionality with safety risks (e.g., implant programming) (21 CFR 812.25(c), (d));
· Software Bill of Materials (21 CFR 812.25(c), (d)); and
· General Labeling – Connectivity and associated general cybersecurity risks, updateability/process (21 CFR 812.25(f)).

The contents and format of those documents are unclear for me, can you please help me and/or tell me where I can find some examples/templates of those documents.

Thanks in advance

Best regards



Trusted Information Resource
A reasonable launch pad to consult is Homepage | CISA, I often refer to the dedicated SBOM page.

There are many different ways to tackle these issues; each of them needs to interface with classical elements of regulated medical device design and manufacture including:
  • Risk Management; see AAMI TIR57 for suggestions on a parallel process (to Safety Risks per 14971) for Security risks
  • Usability (use cases, user classes)
  • Design of device interfaces (both hardware and user interfaces)
  • Software Configuration Management (a la management of product data structures)
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