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Gaps Remain In US FDA's Response Procedures For Cybersecurity Events, OIG Says

Executive Summary

FDA's policies and procedures do not adequately address how to handle post-market device cybersecurity events and the agency had not adequately tested its ability to respond to emergencies arising from such events, US HHS' investigative arm says. But the top cybersecurity official at FDA's device center says OIG's report is "incomplete and inaccurate."


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