FDA Guidance: Contents of Premarket Submissions for Management of Cybersecurity in Medical Devices, 10/14

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In October, 2014 CDRH and CBER published this guidance to industry and FDA staff to assist the industry by identifying the issues related to cybersecurity that manufacturers should consider in the design and development of their medical devices, as well as in preparing premarket submissions for those devices. This guidance provides recommendations to consider and information to include in FDA medical device premarket submissions for effective cybersecurity management.

Recommendations include quality assurance measures such as hazard analyses, trace matrices, risk mitigation and technical measures, such as user authentication, code authentication, and detection of security breaches.