Tag archives: FDA

FDA issues final guidance on postmarket medical device cybersecurity

Photo of Anna Rudawski (US)By Anna Rudawski (US) on Posted in Compliance and risk management, Regulatory response
Data Protection Report - Norton Rose FulbrightOn December 28, 2016, the U.S. Food and Drug Administration (FDA) released final guidance on the management of cybersecurity vulnerabilities for marketed and distributed medical devices.  The guidance establishes a risk-based approach for the reporting of medical device cybersecurity vulnerabilities to the FDA.… Continue reading

FDA Warns of Link Between Anti-Malware and Medical Device Failure

By on Posted in Compliance and risk management, Regulatory response
Data Protection Report - Norton Rose FulbrightOur sister blog, The Health Law Pulse, has just blogged on the first reported instance of anti-malware causing of a medical device failure. Medical device manufacturers may wish to keep this type of interruption in mind when considering the U.S. Food & Drug Administration’s past guidance regarding the need to balance cybersecurity safeguards and the usability of the medical … Continue reading
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