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Food and Drug Administration (FDA) › Product Enhancements

Tucker Arensberg, P.C.

Food And Drug Administration Issues Draft Guidance On Cybersecurity In Medical Devices

Tucker Arensberg, P.C. on

On January 22, 2016, the Food and Drug Administration (“FDA”) released draft guidance regarding postmarket management of cybersecurity risks in medial devices. This guidance comes over a year after the FDA issued similar...more

Morgan Lewis

Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

Morgan Lewis on

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more

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