FDA Issues Draft Guidance on Cybersecurity for Medical Device Industry

The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity risk. The guidance builds on the framework that FDA established in its earlier guidance, finalized in 2014, for helping manufacturers consider cybersecurity in the design and development of their medical devices.