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FDA updates medical device premarket guidance to include cybersecurity recommendations

October 17, 2018 / Evan Sweeney

Updated guidance issued by the Food and Drug Administration on Wednesday includes several new cybersecurity recommendations for medical devices. Among those changes, the FDA is asking manufacturers to include a list of hardware and software components within each device—known as a “bill of materials”—that could be susceptible to a cyber attack. Earlier this month, FDA Commissioner Scott Gottlieb, M.D., hinted that an update would be coming as part of a broader effort to address what has become a growing concern for the agency. In an increasingly connected healthcare environment, legacy devices have been pegged as a weak link in the ecosystem.