What cybersecurity testing does FDA require for a medical device submission?

FDA expects test cases traced to the device architecture and threat model, covering every interface, with pass and fail results recorded. Penetration testing is required but is not sufficient on its own; reviewers also expect SBOM analysis, control-effectiveness testing, and evidence of a postmarket vulnerability management plan under Section 524B.

Is a single penetration test enough for a 510(k) or PMA?

No. A point-in-time pentest documents only findings, not coverage. Reviewers increasingly ask manufacturers to justify the absence of findings on specific interfaces, which requires test-case-level evidence with traceability, not a summary report.

What is Section 524B?

Section 524B of the FD&C Act, added by the PATCH Act in 2023, requires cyber-device manufacturers to submit a plan to monitor, identify, and address postmarket cybersecurity vulnerabilities, maintain secure development processes, and provide a software bill of materials.

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