Existing software verification activities and, for higher-risk products, third-party testing engagement already present in submission packages.
Adversarial penetration testing with active exploitation attempts, scoped to the threat model, with findings characterized, logged in problem resolution, and verified remediated.
Pen test report with scope derived from threat model and covering network, application, and firmware layers — generic black-box testing unconnected to the threat model does not satisfy FDA expectations.
Maps to
IEC 81001-5-1: §5.7.4 Penetration testing
Requirement text
The manufacturer shall establish an activity (or activities) to identify and characterize weaknesses via tests that focus on discovering and exploiting security vulnerabilities in the health software.
Why this clause exists
Penetration testing subjects the integrated system to attack by personnel or organizations that approach it as an adversary would — with creative techniques, combined attacks, exploitation of interaction effects between components, and methods that fall outside defined test plans. Penetration testing is the only testing activity that is specifically designed to discover what all preceding security activities missed: architectural design decisions that are individually correct but create exploitable paths in combination; implementation errors that passed code review; requirements gaps where the threat model was incomplete. IEC 81001-5-1:2021 clause 5.7.4 requires penetration testing as a distinct activity that validates the security posture of the integrated system, rather than verifying predefined controls. The requirement exists because no finite set of specified test cases can anticipate all attack paths — penetration testing provides an adversarial validation pass that complements the compliance-based testing activities. FDA's premarket cybersecurity guidance explicitly expects penetration testing results for medical devices connecting to network infrastructure, and the absence of penetration testing is a consistent finding in FDA cybersecurity review feedback.
What changed
IEC 81001-5-1:2021 is the first standalone cybersecurity standard purpose-built for health software and medical device software. Published in December 2021, it was adapted from IEC 62443-4-1 (industrial control systems security) to address the unique safety and regulatory context of medical devices — adding health-specific requirements that account for patient safety, clinical workflows, and the manufacturer-HDO relationship.
The standard mirrors IEC 62304's lifecycle structure but adds security-specific activities at every phase — planning, development, testing, release, and maintenance. It requires security risk management to be integrated with ISO 14971 safety risk management, not treated as a separate IT concern. FDA formally recognized it as Consensus Standard 13-122 on December 19, 2022 and references it as providing one acceptable framework for satisfying the cybersecurity requirements of Section 524B(b)(2), which requires manufacturers to design, develop, and maintain processes and procedures to provide a reasonable assurance that cyber devices and related systems are cybersecure.
EU MDR harmonization was originally targeted for May 2024 but postponed to May 2028. Despite this delay, Notified Bodies and Competent Authorities universally recognize it as "state of the art" for health software cybersecurity under MDR GSPR Annex I, Section 17.2. Missing or inadequate cybersecurity documentation is already a top cause of Notified Body major non-conformities for SaMD. A December 2025 Interpretation Sheet (ISH1:2025) clarified software item classification into maintained, supported, and required software categories, affecting risk transfer and post-market obligations.
Common gaps (what we see in audits)
- Penetration testing scope not derived from threat model — Penetration tests are performed as black-box testing without scoping to the threat model's identified attack surfaces. FDA expects tests on the final production-equivalent version covering network, application, and firmware layers. Generic pen testing misses device-specific attack vectors.