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Monthly Archives: February 2016

FDA Issues Draft Guidance on Postmarket Cybersecurity Programs for Medical Devices

Posted in Being Proactive, Data Security, FDA, Pharma

In 2014, the Food and Drug Administration (“FDA”) articulated its expectations for how device manufacturers address cybersecurity premarket in Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Recently, the FDA released complementary draft guidance in Postmarket Management of Cybersecurity in Medical Devices. In the new guidance, the FDA explains what constitutes an… Continue Reading