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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Postmarket articles.
Every article in our archive tagged Postmarket.
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.
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Showing 8 of 20 articles tagged Postmarket · Page 2 of 2
FDA· Apr 10, 2026
FDA Postmarket Cybersecurity for Cleared
FDA postmarket cybersecurity guidance for cleared medical devices: SBOM monitoring, validated patches, CVD, and 21 CFR Part 806 reporting under Section 524B.
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Lifecycle· Apr 9, 2026
Legacy Medical Device Cybersecurity Risks in Hospitals
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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Lifecycle· Nov 5, 2025
Legacy Medical Device Cybersecurity (2026)
Legacy Medical Device Cybersecurity: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.
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Risk· Jul 13, 2025
PATCH Act & Legacy Medical Devices
The PATCH Act only applies to new medical devices. Legacy medical devices pose significant cybersecurity risks because they lack modern protections.
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FDA· Apr 13, 2025
Medical Device Cybersecurity Standards
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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International· Feb 16, 2024
MDSAP for Medical Device Compliance
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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International· Feb 16, 2024
IMDRF Cybersecurity Guidance Explained
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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