The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA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
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The Food and Drug Administration has released a plan to improve medical device safety. The plan calls for increased funding to develop an active surveillance capability for FDA’s National Evaluation System for health Technology (NEST) and conduct post-market studies to evaluate specific safety concerns. The
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