FDA to Update Premarket Guidance for Medical Device Security

FDA to Update Premarket Guidance for Medical Device Security

FDA Commissioner Scott Gottlieb, on 5th September said, “FDA is planning to update its premarket guidance for medical device security.” He further added, “We have made significant progress to improve the cybersecurity of medical devices. But the industry is rapidly evolving with respect to data security and we need to keep up the pace.” This guidance will have recommendations for manufacturers for the protection against moderate and major ricks which are capable of disrupting & exploiting clinical operations through remote attack. He further added that the FDA will share number…

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