Every article in our archive tagged eSTAR.
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 9 of 9 articles tagged eSTAR
FDA Submission Issue Request (SIR) response strategy for cybersecurity: eSTAR prep checklist, common 524B gaps, and how to answer without restarting review.
Read article
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.
Read article
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.
Read article
What the FDA's Feb 2026 guidance expects in interoperability labeling for connected medical devices, and where each element sits in the eSTAR package.
Read article
How to design penetration test cases from a medical device threat model, the methodology that bridges STRIDE-style threats and concrete bench test.
Read article
What the FDA's Feb 2026 guidance expects in the unresolved cybersecurity anomalies assessment, how to document residual risk, and the deficiency pattern.
Read article
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.
Read article
DAST is a subset of FDA-required penetration testing. What the Feb 2026 guidance expects in eSTAR Slot 7, and why a Burp scan alone will fail review.
Read article
Every cybersecurity artifact the FDA expects in an eSTAR 510(k): Section Q mapping, SBOM, threat model, SPDF evidence, and traceability matrix.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.
