SBOM & Supply Chain· Jun 1, 2026
SBOM EOS, EOL, & LoS for FDA 524B
EOS vs EOL vs Level of Support in your medical device SBOM: what Section 524B requires, how to express it in CycloneDX and SPDX, and how to defend it.
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Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.
Showing 6 of 18 articles tagged Postmarket · Page 2 of 2
EOS vs EOL vs Level of Support in your medical device SBOM: what Section 524B requires, how to express it in CycloneDX and SPDX, and how to defend it.
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Legacy medical devices - Windows XP infusion pumps, unpatched imaging, flat VLANs - are the #1 hospital attack surface. Scoring, segmentation, and a 90-day fix plan.
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The PATCH Act became section 524B and covers qualifying cyber-device submissions, including some legacy-device modifications. See what it requires, who is exempt, and how to secure legacy medical devices.
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The 14 medical device cybersecurity standards FDA reviewers expect - ISO 14971, IEC 62304/81001-5-1, AAMI TIR57/TIR97, UL 2900 - mapped to SPDF artifacts.
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How MDSAP works in 2026: the five participating regulators, the audit model, jurisdiction-specific requirements, and where cybersecurity evidence gets audited.
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How IMDRF N60, N70, and N73 shape medical device cybersecurity expectations at the FDA, TGA, and Health Canada, and how to build one package that travels.
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