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FDA Issues More Guidance on Intentional Adulteration of Food Rule

USA - February 26 2020 As part of its implementation of the Food Safety Modernization Act, the U.S. Food & Drug Administration (FDA) published a final rule four years ago…

FDA Final Order Exempts Certain Medical Devices From Premarket Notification

USA - January 8 2020 At the end of 2019, the Food and Drug Administration (FDA) published a final order and a final amendment exempting several categories of medical…

FDA Issues Final Guidance on Review of Denial of Medical Device Export Certificates

USA - November 19 2019 Before certain medical devices can be lawfully exported from the United States, some countries require American companies to obtain a Certificate to…

FDA Fall Fling: Medical Device Guidance Activity Flourishes

USA - October 21 2019 The FDA closed the federal fiscal year with a flurry of activity by issuing multiple guidance documents on various medical device topics, including…

FDA Issues Final Rule on Appeals of Medical Device Decisions

USA - July 17 2019 In 2012, as part of the FDA Safety and Innovation Act (FDASIA), Congress required the FDA to furnish, upon request, a “substantive summary of the…