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Product Enhancements

Food And Drug Administration Issues Draft Guidance On Cybersecurity In Medical Devices

by 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On January 22, 2016, the Food and Drug Administration (“FDA”) released draft guidance regarding postmarket management of cybersecurity risks in medial devices.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

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

by 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

FDA Draft Guidance on Device “Product Enhancements” Could Lead to Increased Recalls

by Ropes & Gray LLP on

On February 22, 2013, the Food and Drug Administration (“FDA”) issued draft guidance explaining when a change to a medical device constitutes a medical device recall as opposed to a “product enhancement.” This draft guidance...more

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Cybersecurity

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