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Every article in our archive in FDA Compliance.
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 in FDA Compliance
eSTAR v7.0 cybersecurity slots are identical for IVD and nIVD submissions, but the content reviewers expect is not. Here's how to fill each section correctly.
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What the FDA's Feb 2026 guidance expects in interoperability labeling for connected medical devices, and where each element sits in the eSTAR package.
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What the MDS2 / HSCC Manufacturer Disclosure Statement for Medical Device Security covers, what the FDA's Feb 2026 guidance expects in the disclosure.
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What the FDA's Feb 2026 guidance expects in the unresolved cybersecurity anomalies assessment, how to document residual risk, and the deficiency pattern.
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Section 524B(b)(1) makes patchability statutory. What the FDA's Feb 2026 guidance expects in the patch and update mechanism test evidence, the test cases.
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Class I, II, III doesn't decide your FDA cybersecurity burden. Section 524B's cyber-device test and whether you file a premarket submission do.
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