Last reviewed: May 1, 2026
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MedTech developers, do you know which penetration testing methodology the FDA actually prefers for medical device submissions?
In this episode, Christian and Trevor explain the differences between black, grey, and white box penetration testing and how each impacts the completeness and realism of cybersecurity assessments. They highlight why regulators increasingly expect deeper testing supported by source-code-level insights. They also outline the risks, costs, and delays manufacturers face when choosing insufficient testing approaches during FDA submission.
Key points:
(01:25) Learn how black box testing mimics an attacker with no prior knowledge.
(06:27) How grey box testing blends limited credentials, architecture insight, and direct communication with engineers to expand visibility.
(08:29) Why white box testing includes access to full documentation, processes, and source code.
(10:20) How attacker timeframes differ from tester timeframes.
(11:29) How the FDA’s static analysis, SBOM, and risk evaluation requirements tie naturally into white box testing workflows.
(15:06) Learn why choosing black box testing to save money often results in higher total costs after FDA rejection.
(17:47) Hear why “buy once, cry once” applies to penetration testing.
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