FDA To Require Demonstration Of Cybersecurity Safeguards For Pre-Market Submissions Of Certain Medical Devices – Security

On March 29, 2023, and March 30, 2023, the U.S. Food & Drug
Administration (“FDA”) issued a series of
FAQs1 and a guidance document2 clarifying the
agency’s intended implementation of the Consolidated
Appropriations Act of 2023 (the “Omnibus”), which amended
Section 524B of the Food, Drug…

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