The FDA’s electronic submission system, eSTAR, requires structured cybersecurity artifacts for 510(k), de novo, and PMA submissions, as well as device modifications. Our guide shows how to complete each section, map your docs, and stay compliant with the latest expectations. Use these graphics and resources to navigate a critical process for getting your products to market.

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The mind map below illustrates the typical premarket artifacts required for FDA submissions with information regarding their requirements and contents.