Introduction: Your Cybersecurity Story for FDA

Imagine you're telling FDA the complete story of how your device stays secure. Every document you submit is a chapter in that story - from how you identified threats to how you'll handle problems after launch. Miss a chapter, and FDA sends you a deficiency letter asking for the missing pieces.

This chapter will guide you through:

• Understanding what FDA legally requires vs. expects
• Creating each required cybersecurity document
• Avoiding common submission pitfalls
• Organizing your submission for success

The goal isn't just compliance - it's demonstrating that you've thoughtfully addressed cybersecurity throughout your device's lifecycle.