Every article in our archive tagged Cybersecurity.
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 6 of 6 articles tagged Cybersecurity
CLIA-waived test cybersecurity: why point-of-care devices used by untrained staff need strong security, and what FDA guidance recommends in the premarket submission.
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Breakthrough Device designation speeds FDA interaction but waives no cybersecurity requirement. Here is how Section 524B applies to Breakthrough devices in 2026.
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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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Q-Sub vs Pre-Sub for FDA cybersecurity: what they are, how they differ, and when to use a Pre-Submission to de-risk Section 524B threat models, SBOMs, and pen tests.
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When to use an FDA Submission Issue Request after a qualifying hold letter, how to frame cybersecurity questions, and why the formal response deadline still applies.
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