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Understanding Cybersecurity in FDA Medical Devices Guidance: Considerations and Solutions

Apr 01, 2024

thumbnail-Understanding Cybersecurity in FDA Medical Devices Guidance-TXOne white paper

As technology continues to evolve, medical devices are more frequently built using software components that simultaneously increase efficiency and the risk factor of being exploited. In response, regulations have been put into place to compel manufacturers into taking their cybersecurity posture more seriously. The US FDA issued the “Cybersecurity in Medical Devices: Quality System Considerations and Content for Premarket Submissions” guideline to provide organizations the ability to proactively address potential vulnerabilities before market entry. In essence, this was created so that security would be a factor taken into serious consideration during device design, thereby reducing the risk of exploitation once it has entered the market.

The scope of application for this FDA guidance encompasses all devices requiring cybersecurity consideration such as those with software functions and those containing software (including firmware) or programmable logic as well as any devices that can connect to the network. TXOne Networks offers insights and strategies into parsing the guidance, analyzing the FDA’s recommendations to include cybersecurity information in premarket submissions, pointing out the most crucial cybersecurity design and content submissions, and providing solutions from the TXOne perspective.

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