Medical device cybersecurity guides
Reference pages on what FDA asks for and how to produce it: Section 524B, SBOM, threat modeling, and testing. Each guide cites the statute, guidance, or standard it relies on and links the related chapter of the free Medical Device Cybersecurity Book.
- Threat modeling guideSTRIDE Threat Modeling for Medical Devices: DFDs to FDA Threat TableHow to threat model a medical device with STRIDE: build the data flow diagram, draw trust boundaries, fill the threat table, score risk, and map to ISO 14971.Mohamad Foustok · Updated
- FDA 524B guideFDA Section 524B Requirements: What Cyber Devices Must SubmitSection 524B of the FD&C Act explained: the cyber device definition, the three 524B(b) obligations, the eSTAR mapping, screening, and the 2026 guidance.Jose Bohorquez · Updated
- FDA SBOM guideFDA SBOM Requirements for Medical Devices: What to Submit and MaintainFDA SBOM requirements for medical devices: Section 524B(b)(3), the minimum elements, support status and end-of-support dates, CycloneDX vs SPDX.Andres Echeverry · Updated