Every article in our archive in FDA Compliance.
Showing 6 of 6 articles in FDA Compliance
The 8 eSTAR v7.0 cybersecurity slots are identical for IVD and nIVD submissions, but the content reviewers expect is not. The IVD-specific guidance, slot by slot, and the deficiency patterns we see most.
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What the FDA's Feb 2026 guidance expects in interoperability labeling for connected medical devices, what content goes in user docs, where it sits in eSTAR v7.0, and how to align with IEEE 11073, HL7 FHIR, and DICOM expectations.
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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, and where it fits in eSTAR v7.0 labeling.
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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 that follows when this section is missing or thin.
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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 reviewers look for, and the most common deficiency patterns.
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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. Here's how it actually works.
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