FDA Finalizes Guidance on Cybersecurity Use in Medical Devices

The FDA finalized its updated guidance Tuesday on how medical device manufacturers can tighten cybersecurity in the face of rapidly evolving online threats to patients and the health-care system.

The Food and Drug Administration issued a draft of the newly finalized guidance in April 2022 that updated its recommendations dating back to 2014. The agency said its goal was to emphasize the importance of ensuring that medical devices are designed securely to mitigate emerging cybersecurity risks throughout life of the product, and to more clearly outline the agency’s recommendations for premarket submission information to address cybersecurity concerns.

The guidance makes ...