U.S. Food and Drug Administration. (2014). Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff. U.S. Department of Health and Human Services.
This guidance provides recommendations to consider and information to include in FDA medical device premarket submissions for effective cybersecurity management. Effective cybersecurity management is intended to reduce the risk to patients by decreasing the likelihood that device functionality is intentionally or unintentionally compromised by inadequate cybersecurity.