Penetration testing for medical devices submitted to the FDA can fail not due to the quality of the testing, but because the scope of the test was not aligned with the relevant threats. A common issue is testing only the device itself, while neglecting companion apps or cloud endpoints that an attacker could exploit to reach a patient. The FDA requires that penetration test reports demonstrate an unbroken line from threat model to scope, findings, and patient risk, with the threat model being crucial for defining a defensible scope that considers potential harm. AI
IMPACT Ensures medical device cybersecurity testing aligns with FDA requirements, potentially impacting patient safety and product approval timelines.
RANK_REASON Article discusses best practices for penetration testing of medical devices, a specific type of product, rather than a novel release or major industry shift.
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