Every article in our archive in Compliance.
Showing 9 of 9 articles in Compliance
Section 524B applies to a connected auto-injector when the device constituent has software and any electronic interface, regardless of 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. What attaches, what postmarket rules cover the rest.
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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, what artifacts satisfy each, and the deficiency patterns reviewers flag most.
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How to run CAPA for medical device cybersecurity findings: when a vulnerability or FDA deficiency triggers a CAPA, what evidence closes it, and how the QMSR loop ties to §524B postmarket obligations.
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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 manufacturers should align their premarket and postmarket programs to satisfy both reviewers and hospital procurement.
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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 Feb 2026 premarket cybersecurity guidance.
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IEC 62304 software safety classes (A/B/C) and FDA device classes (I/II/III) are not equivalent. See how each one drives cybersecurity evidence under Section 524B and the Feb 3, 2026 guidance.
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