Navigating Cybersecurity during FDA eSTAR Submissions
Garrett Schumacher, MS, CISSP Published on: 06/08/2025
The FDA’s electronic submission system, eSTAR, requires structured cybersecurity artifacts for 510(k), de novo, and PMA submissions. 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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