Postmarket Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Postmarket Management of Cybersecurity in Medical Devices." FDA is issuing this guidance to inform industry and FDA staff of the Agency's recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. The guidance clarifies FDA's postmarket recommendations with regards to addressing cybersecurity vulnerabilities and emphasizes that manufacturers should monitor, identify, and address cybersecurity vulnerabilities and exploits as part of the postmarket management of their medical devices.