Deep 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 245 articles · Page 1 of 21
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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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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