FDA Premarket Cybersecurity Crosswalk
FDA premarket cybersecurity guidance, requirement by requirement — SBOM, penetration testing, and coordinated disclosure mapped to IEC 81001-5-1 and ISO 13485.
Group by:
Design & Development
| FDA Cybersecurity Requirement | IEC 81001-5-1 Mapping | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §V.A.1, V.B.2 | 5.3 | Threat Model Documentation | View → | |
| §V.A.2 | 7 | Cybersecurity Risk Assessment | View → | |
| §V.A.4, VII.C.3, Appendix 4 | 8 | Software Bill of Materials | View → | |
| §V.C | 5.7 | Penetration Testing Evidence | View → | |
| SOUP Risk Assessment | View → | |||
| §V.A.4, VII.C.3, Appendix 4 | SBOM Documentation and Maintenance | View → | ||
| §Appendix 1.A | Authentication Controls for Medical Devices | View → | ||
| §Appendix 1.B | Authorization Controls and Least Privilege | View → | ||
| §Appendix 1.C | Cryptography Selection and Implementation | View → | ||
| §Appendix 1.D | Code, Data, and Execution Integrity | View → | ||
| §Appendix 1.E | Confidentiality of Device Data and Credentials | View → | ||
| §Appendix 1.F | Security Event Detection and Logging | View → | ||
| §Appendix 1.G | Cyber Resiliency and Recovery Design | View → | ||
| §V.A.3 | Interoperability Cybersecurity Considerations | View → | ||
| §V.A.5 | Security Assessment of Unresolved Software Anomalies | View → |
Measurement, Analysis & Improvement
Outsourcing & Purchasing
Production & Service Provision
Other standards
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