CROSSWALK
FDA Premarket Cybersecurity Crosswalk
Requirement-by-requirement breakdown of FDA premarket cybersecurity guidance. Maps each requirement to IEC 81001-5-1 and ISO 13485.
Cybersecurity
| FDA Cybersecurity Requirement | IEC 81001-5-1 Mapping | Requirement | Gaps | Details |
|---|---|---|---|---|
| §V.A.1, V.B.2 | 5.3 | Threat Model Documentation | 1 | View → |
| §V.A.2 | 7 | Cybersecurity Risk Assessment | 1 | View → |
| §V.A.4, VII.C.3, Appendix 4 | 8 | Software Bill of Materials | 1 | View → |
| §V.A.6, VI.B, VII.C.2 | 6 | Vulnerability Assessment and Management | 1 | View → |
| §Appendix 1.H, VI.B, VII.D | 6 | Patch and Update Management Plan | 1 | View → |
| §VI.B, VII.C.1 | 9 | Coordinated Vulnerability Disclosure | 1 | View → |
| §V.A.6, VI.B, VII.E | 6 | End-of-Life Cybersecurity Plan | 1 | View → |
| §V.C | 5.7 | Penetration Testing Evidence | 1 | View → |
Software Components
| FDA Cybersecurity Requirement | IEC 81001-5-1 Mapping | Requirement | Gaps | Details |
|---|---|---|---|---|
| SOUP Identification and Management | 1 | View → | ||
| SOUP Risk Assessment | 1 | View → | ||
| §V.A.4, VII.C.3, Appendix 4 | SBOM Documentation and Maintenance | 1 | View → | |
| §V.A.6, VI.B, VII.C.2 | 6 | Vulnerability Monitoring and Response | 1 | View → |
| Open Source License Compliance | 1 | View → |
Other standards
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