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Every article in our archive in Compliance.
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 12 of 12 articles in Compliance
Where FDA premarket cybersecurity artifacts live in an ISO 13485 / QMSR quality system: DHF, risk management file, DMR, and postmarket - clause-by-clause map.
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Cybersecurity for CLIA high-complexity labs: HIPAA, 21 CFR Part 11 data integrity, LIMS hardening, vendor patching, AI/cloud analytics, and CMS/CAP inspection readiness.
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The FDA PCCP guidance isn't AI-only. Use a predetermined change control plan for cybersecurity patches, firmware updates, and SBOM component swaps.
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FDA Section 524B applies to connected auto-injectors when the device constituent has software and any electronic interface, whether CDER or CDRH leads review.
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What happens if you fail an FDA cybersecurity inspection: the 483-to-consent-decree enforcement ladder and the commercial fallout for device makers.
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How to document update cadence for an FDA §524B submission: the regular cycle and the out-of-cycle expedited path reviewers expect under §524B(b)(2)(B).
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FDA Section 524B applies to any new premarket submission for a cyber device, including legacy platforms.
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A subsection-by-subsection walkthrough of FDA Section 524B for cyber medical devices: what §524B(a), (b)(1), (b)(2), (b)(3), (b)(4), and (c) require.
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How to run CAPA for medical device cybersecurity findings: when a vulnerability or FDA deficiency triggers a CAPA, and what evidence closes it out.
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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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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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IEC 62304 software safety classes (A/B/C) and FDA device classes (I/II/III) are not equivalent.
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