What cybersecurity testing deliverables support an FDA 510(k) submission?

Cybersecurity testing deliverables that support FDA premarket review include:

• Cybersecurity test plans that define test objectives, scope, and risk-based rationale.
• Summaries of vulnerability assessment and penetration testing results with traceability to identified risks and implemented risk control measures.
• Documentation formatted for FDA review, including narrative descriptions, tables, and traceability matrices.
• Support for integrating cybersecurity testing evidence into the overall FDA 510(k) submission structure.