FDA outlines cybersecurity recommendations for medical device manufacturers

January 29, 2016

The U.S. Food and Drug Administration today issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the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 The draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the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. The draft guidance is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices, at all stages in their lifecycle, in the face of potential cyber threats.

Cybersecurity threats to medical devices are a growing concern. The exploitation of cybersecurity vulnerabilities presents a potential risk to the safety and effectiveness of medical devices. While manufacturers can incorporate controls in the design of a product to help prevent these risks, it is essential that manufacturers also consider improvements during maintenance of devices, as the evolving nature of cyber threats means risks may arise throughout a device’s entire lifecycle.

“All medical devices that use software and are connected to hospital and health care organizations’ networks have vulnerabilities—some we can proactively protect against, while others require vigilant monitoring and timely remediation,” said Suzanne Schwartz, M.D., M.B.A., associate director for science and strategic partnerships and acting director of emergency preparedness/operations and medical countermeasures in the FDA’s Center for Devices and Radiological Health. “Today’s draft guidance will build on the FDA’s existing efforts to safeguard patients from cyber threats by recommending medical device manufacturers continue to monitor and address cybersecurity issues while their product is on the market.”