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Focus on Regulation

Tag Archives: intended use regulation

FDA: Implementation of Amended Intended Use Regulations Delayed Until March 21, 2017

On February 7, 2017, the Food and Drug Administration (FDA) delayed implementation of its January 9, 2017, final rule addressing the regulation of tobacco products as drugs, devices, or combination products.  That rule, which also amended the intended use regulations for drugs and devices, was to go into effect today, February 8, 2017; however, implementation

KNOWLEDGE ALONE ≠ INTENT: FDA Proposes To Trim One Basis for Determining “Intended Use” of Drugs and Devices

Last week, the U.S. Food and Drug Administration (FDA) published a proposed rule, 80 Fed. Reg. 57756 (Sept. 25, 2015), that at first blush is devoted to clarifying when a tobacco product may be subject to FDA’s regulation as a drug, device, or combination product vs. a tobacco product.  Slipped within this proposed rule, however,