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FDA medical device plan zeros in on cybersecurity, public-private partnership

April 19, 2018 / Jessica Davis

The Food and Drug Administration released its plan to improve medical device safety, which includes a reorganization of its medical device center and a Congressional plan to launch a public-private partnership focused on cybersecurity. The five-point plan released Tuesday outlines a plan to consolidate offices within its device center, which oversees pre- and post-market activities. As part of the plan, the FDA will require manufacturers to ensure medical devices are capable of being updated and receiving security patches. FDA Commissioner Scott Gottlieb, MD, also said the agency is contemplating forcing manufacturers to publicly disclose known cybersecurity issues.