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FDA Reaches Agreement with Industry for Reauthorization of Medical Device User Fees

The Food and Drug Administration has issued a statement announcing that the FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations...more

FDA Issues Proposed Guidelines for Managing Cybersecurity in Medical Devices

The Food and Drug Administration recently issued a draft guidance for managing cybersecurity in medical devices. The guidance document provides the FDA’s postmarket recommendations for monitoring, identifying, and addressing...more

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