Sunday, June 16, 2013

FDA Draft Guidance on Medical Device Cybersecurity

Guidance Documents (Medical Devices and Radiation-Emitting Products) > Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff:

"This guidance provides recommendations to consider and document in FDA medical device premarket submissions to provide effective cybersecurity management and to reduce the risk that device functionality is intentionally or unintentionally compromised."

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