Who does cybersecurity testing support apply to?

Cybersecurity testing support applies to:

• Manufacturers of software-enabled or connected medical devices that include cybersecurity information as part of an FDA 510(k) submission.
• Regulatory and quality teams that prepare and maintain submission-ready documentation.
• Engineering and product teams that implement and verify cybersecurity risk control measures.
• Organizations that seek to align internal cybersecurity testing activities with FDA premarket review expectations.