FDA Device Compliance: Secure by Design

Security at Submission

The FDA now expects cybersecurity to be a core part of every premarket medical device submission. Compliance isn’t just paperwork — it’s proof that your device is safe, resilient, and ready for patient use. Submissions that fall short risk rejection, costly redesigns, and delayed approvals.

This guide helps you build compliance into your device from the start.

What You’ll Learn:

• The FDA’s updated cybersecurity requirements and objectives
• The documentation and risk management reviewers now expect
• Key security categories (design, updates, SBOMs) and how to address them
• How DigiCert Device Trust solutions help ensure lifecycle security and compliance