Compliance· Jun 18, 2026
HHS 405(d) HICP Practice #9 for 524B
How HHS 405(d) and the Health Industry Cybersecurity Practices (HICP) Medical Device Security practice maps to FDA Section 524B artifacts, and how.
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Showing 12 of 67 articles tagged FDA · Page 3 of 6
How HHS 405(d) and the Health Industry Cybersecurity Practices (HICP) Medical Device Security practice maps to FDA Section 524B artifacts, and how.
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What an FDA pen test must include and how recent it must be under the Feb 3, 2026 guidance: version match, re-testing after changes, and fixing findings before you file.
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When HIPAA applies to medical device manufacturers, how the 2025 Security Rule NPRM raises the bar, and how HIPAA obligations intersect with the FDA's.
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Which EHR and EMR systems medical devices connect to (Epic, Oracle Health, MEDITECH, Allscripts, athenahealth), the integration protocols (HL7, FHIR.
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What FDA guidance recommends for infusion pump cybersecurity submissions in 2026: threat model focus areas, Section 524B evidence, and the deficiencies reviewers cite.
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What the FDA's Feb 3, 2026 final premarket cybersecurity guidance expects from a medical device incident response plan, who owns it, and the documents.
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IEC 62304 software safety classes (A/B/C) and FDA device classes (I/II/III) are not equivalent.
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What a DFD is, the five DFD elements, and how data flow diagrams feed STRIDE threat modeling and the FDA's Security Architecture Views in a 2026.
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Where containers appear in medical devices, the testing FDA guidance recommends under the Feb 3, 2026 guidance, and how container evidence maps to eSTAR v7.1.
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eSTAR v7.1 cybersecurity attachments are identical for IVD and nIVD submissions, but the content reviewers expect is not. Here's how to fill each section correctly.
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When a chip vendor's SBOM is enough, when it isn't, and what changes the moment a MedTech team modifies modem, radio, or SoC firmware in the device.
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What the FDA's Feb 2026 guidance expects in the unresolved cybersecurity anomalies assessment, how to document residual risk, and the deficiency pattern.
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