Four ways to meet the new FDA guidance for medical device security

The FDA’s 2023 cybersecurity guidance, while demanding, sets the stage for a safer future where medical devices are resilient to evolving cyber threats.

By Curtis Yanko, CodeSecure

The FDA recently issued updated guidance on best practices for medical device cybersecurity, a progressive step forward from its 2014 recommendations. This revision underscores the need for manufacturers to adopt proactive security measures, integrating them into the very design and fabric of devices.

The underlying message of this new guidance is that manufacturers are encouraged to adopt a “security by design” methodology. This represents a significant departure from prevailing manufacturing and design mindsets, and necessitates considerable investments in new technologies and training.

A cornerstone of this new guidance is its focus on software supply chain security. Manufacturers aren’t just expected to produce secure devices; They are mandated to continuously …

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