Navigating the new medical device cybersecurity requirements

The FDA's updated cybersecurity rules under Section 524B of the FD&C Act bolster medical device security to safeguard patient health and privacy. This white paper outlines the essentials:

Definition of "cyber devices" and required premarket information from manufacturers
Mandatory cybersecurity strategies, including vulnerability monitoring, patching, and coordinated disclosure
Use of the NIST Cybersecurity Framework for robust device security

These FDA measures and guidance for manufacturers are crucial for countering threats to connected medical technologies. The full white paper details navigating Section 524B to ensure your devices are secure by design.

Vendor:: Wind River
Posted:: Jun 17, 2024
Published:: Jun 17, 2024
Format:: PDF
Type:: White Paper

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