Every article in our archive tagged FDA.
Showing 12 of 71 articles tagged FDA · Page 1 of 6
How to run a design FMEA (dFMEA) for a connected medical device, link it to the ISO 14971 risk file, and hand off cyber-triggered failure modes to the threat model the FDA expects.
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How to wire SAST, SBOM, secrets, container, and signature gates into a medical-device CI/CD pipeline so the SPDF produces the evidence FDA reviewers expect under the Feb 3, 2026 guidance.
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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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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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What medical device cybersecurity actually costs in 2026 - the four cost drivers, fixed-fee vs hourly pricing, premarket vs postmarket budget lines, and the cost of delay.
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How SPDF activities map to IEC 62304 software lifecycle processes - the exact crosswalk FDA reviewers expect, where they overlap, and where 62304 falls short.
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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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FMEA covers random and systematic failure modes; threat modeling covers adversarial action. Both are required for a §524B submission, and they do not substitute for each other. Here is how to scope them, link them, and avoid the gap.
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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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What the FDA's Feb 3, 2026 guidance expects for penetration test recency, version-match, post-change re-testing, and pre-submission remediation, plus when a delta re-test will do and when you need a full one.
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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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