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
PreSTAR vs eSTAR explained: PreSTAR is the voluntary FDA template for Q-Submissions, eSTAR is required for 510(k) and De Novo. How cybersecurity carries across.
Read article
eSTAR v7.1 cybersecurity attachments 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
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)(2) makes patchability statutory. What the FDA's Feb 2026 guidance expects in the patch and update mechanism test evidence, the test cases.
Read article
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.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.
