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FDA Issues Guidance on Medical Device Cybersecurity Quality System Considerations

The U.S. Food and Drug Administration (FDA) has released its Final Guidance on cybersecurity considerations for medical devices to assist device manufacturers in preparing premarket submissions.

Released in late September, the Final Guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” provides recommendations on cybersecurity device design, labeling, and documentation that the FDA recommends be included in premarket submissions for medical devices that pose a potential cybersecurity risk.

The Final Guidance also recommends that device manufacturers consider adopting a secure product development framework (SPDF), a set of processes aimed at reducing the number and severity of potential vulnerabilities in a given device throughout the device’s entire lifecycle.

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Near and Far Field Measurements with a Vector Network Analyzer

For optimal performance in over-the-air RF systems, antennas must meet specific requirements. Performance parameters like size, wind-loading, environmental ruggedness, transmission pattern, bandwidth, and power handling capability should be considered. Methods of measuring the transmission (or reception) pattern that determines antenna gain with a VNA will be examined in this article.

Read the complete text of the FDA’s Final Guidance on medical device cybersecurity quality system considerations.

The FDA will host a webinar on the Final Guidance in early November for those interested in learning more about the agency’s recommendations on cybersecurity considerations for medical devices.

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