Compliance· Oct 7, 2026
CLIA-Waived Test Cybersecurity: Point-of-Care Risks
CLIA-waived test cybersecurity: why point-of-care devices used by untrained staff need strong security, and what the FDA expects in the premarket submission.
Read articleDeep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.
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 246 articles · Page 1 of 21
CLIA-waived test cybersecurity: why point-of-care devices used by untrained staff need strong security, and what the FDA expects in the premarket submission.
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What is MedTech, and how does it differ from a medical device or life sciences? Clear definitions, from scalpels and sutures to connected cyber devices.
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FDA cybersecurity deficiency response timeline: the 180-day clock, how holds work for 510(k), De Novo and PMA, and a week-by-week plan to answer on time.
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Ransomware and medical devices: how attacks reach connected devices, what the FDA's 2026 premarket guidance expects, and the design controls that limit harm.
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SBOM for SaMD and cloud components: what the FDA expects for cloud services, containers and third-party APIs, and how to keep the SBOM current after release.
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What is a cyber device under FDA Section 524B? The three-part legal test, how the FDA reads internet connection, and a quick check for your own device.
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What the FDA actually wrote in cybersecurity Additional Information letters: eight recurring deficiencies ranked by frequency, root causes, and the artifact that closes each.
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Home use vs hospital device cybersecurity: which controls the HDO environment provides, which the device must carry itself, and how the FDA reviews each case.
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How CVSS scoring works for medical devices, a worked scoring example, and why a raw score is not a patient risk score under FDA guidance.
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Medical device software development explained: design controls, IEC 62304 safety classes, SOUP management, verification, validation, and FDA documentation.
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Embedded Linux vs Windows IoT Enterprise LTSC for medical devices: attack surface, isolation, secure boot, patching, SBOM, and what FDA reviewers actually look at.
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How your Indications for Use statement and predicate choice change the cybersecurity scope of a 510(k): use environment, harm ceiling, pen test scope, and Special 510(k) eligibility.
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