FDA: Postmarket Management of Cybersecurity in Medical Devices

FDA issues guidance to inform industry and FDA staff of recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical device.

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Source: U.S. Food & Drug Administration, Center for Devices & Radiological Health dated 12/28/16

“The Food and Drug Administration (FDA) is issuing this guidance to inform industry and FDA staff of the Agency’s recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical devices. In addition to the specific recommendations contained in this guidance, manufacturers are encouraged to address cybersecurity throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device1. A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats. The exploitation of vulnerabilities may represent a risk to health and typically requires continual maintenance throughout the product life cycle to assure an adequate degree of protection against such exploits. Proactively addressing cybersecurity risks in medical devices reduces the overall risk to health.”

Click here to access the FDA’s document.