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FDA issues final guidance on postmarket medical device cybersecurity

Photo of Anna Rudawski (US)
By Anna Rudawski (US) on January 5, 2017

On 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.

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

Posted on May 6, 2016

Our 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…

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