FDA updates medical device premarket guidance to include cybersecurity recommendations

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 deviceknown as a bill of materialsthat could be susceptible to a cyberattack.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....