FDA: Draft cybersecurity recommendations for device manufacturers

Editor's Note

The Food and Drug Administration (FDA) on January 15 issued a draft guidance that outlines important steps manufacturers should take to address postmarket management of cybersecurity vulnerabilities in medical devices.

The guidance builds on the FDA’s existing efforts to ensure the safety and effectiveness of medical devices at all stages in their lifecycle in the face of cyber threats.

Cybersecurity threats to medical devices are a growing concern because all devices that use software and are connected to hospital networks have vulnerabilities, according to the FDA.

Comments on the draft guidance will be accepted for 90 days.

The U.S. Food and Drug Administration today issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance details the agency's recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market.