FDA Guidance: Postmarket Management of Cybersecurity in Medical Devices, 12/16

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In December, 2016, the CDRH and CBER branches of the FDA published Guidance for Industry and FDA Staff, Postmarket Management of Cybersecurity in Medical Devices. This document is intended to inform industry and FDA staff of the Agency’s recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. This guidance clarifies FDA’s postmarket recommendations and emphasizes that manufacturers should monitor, identify and address cybersecurity vulnerabilities and exploits as part of their postmarket management of medical devices.

This document highlights that it is essential for device manufacturers to implement comprehensive cybersecurity risk management program as part of postmarket controls. These programs should emphasize addressing the vulnerabilities which may permit the unauthorized access, modification, misuse or denial of use of information that is stored, accessed, or transferred from a medical device to an external recipient, and may impact patient safety.