Every article in our archive tagged eSTAR.
Showing 8 of 8 articles tagged eSTAR
Where containers appear in medical devices, the testing the FDA expects under the Feb 3, 2026 guidance, and how container evidence maps to eSTAR v7.0 Slots 5, 6, 7, and 8.
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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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How to design penetration test cases from a medical device threat model, the methodology that bridges STRIDE-style threats and concrete bench test execution, with traceability the FDA expects in Slot 7.
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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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DAST is a subset of FDA-required penetration testing. What the Feb 2026 guidance expects in eSTAR Slot 7, why a Burp scan alone fails review, and how to build a defensible Testing package.
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What FDA reviewers expect in eSTAR Section Q: SBOM, threat model, SPDF evidence, pen test reports, and a traceability matrix that survives RTA screening.
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