October 2014

Overview and General Principles

On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses cybersecurity principles pertaining to the development of medical devices, documentation that should be submitted with premarket applications, and recognized standards for medical device technology. The FDA pointed to the increasing prevalence of devices connected to system networks and the internet, and the frequent electronic exchange of medical device-related health information, as necessitating effective cybersecurity standards to assure medical device functionality and safety. 

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