“Intended use” is perhaps one of the most important concepts in FDA law. It is significant in two ways. First, a product’s intended use can dictate whether it is even subject to regulation by FDA, and ...
On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, 1 marking the end of an effort ...
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