FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices


Vanessa Burrows, Jennifer Geetter, Daniel Gottlieb and Michael Ryan wrote this bylined article analyzing FDA draft guidance addressing cybersecurity vulnerabilities in medical devices. The authors warned that “if a device manufacturer does not take steps to remediate an uncontrolled risk that is essential to its clinical performance … the FDA will consider such devices to be in violation of the [Food Drug and Cosmetics Act] and subject to enforcement action.”

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