Key Takeaways

1. Security management planning sets the foundation - Without a plan, security activities happen randomly or not at all

2. FDA's five security objectives must all be addressed - Each objective is critical for patient safety

3. Architecture views communicate your security design - FDA needs to understand how security is built in

4. Threat modeling finds problems before attackers do - Systematic analysis reveals vulnerabilities

5. Risk assessment prioritizes your efforts - Focus on the highest risks first

6. Security and safety risks are interrelated - Many security risks become safety risks

7. Defense in depth provides resilience - Multiple layers protect against failure

8. Documentation enables verification - Traceability proves security implementation

9. Planning is iterative - Refine as you learn more

10. Early investment pays off - Security built in costs less than bolted on

Remember: Good security architecture is like a good foundation - invisible when done right, but everything depends on it. The time invested in planning and architecting security will pay dividends throughout your device's lifetime.

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Next Chapter: Secure Development - Implementing your security architecture through secure coding, testing, and validation

Sources

Primary documents for the topics in this section:

1. FDA premarket cybersecurity guidance, Section VI.B Cybersecurity Management Plans, FDA, February 3, 2026.