FDA Clarifies "Intended Use" Regulations: Knowledge Alone ≠ Intent, But Knowledge Certainly Can Be One Element in Establishing the Totality of the Evidence

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (FDA) amended the intended use regulations for drugs and devices. Importantly, though, the amended language is meant to provide clarity for drug and device manufacturers generally regarding FDA's interpretation and application of its existing definitions of "intended use," not to change them. Specifically, the final rule amends the last sentence of 21 C.F.R. § 801.4 (for devices) and 21 C.F.R. § 201.128 (for drugs) to clarify that a manufacturer's knowledge, alone, that its product is prescribed or used by physicians for an uncleared/unapproved use is not proof in and of itself that the manufacturer intends such use, nor is it sufficient to trigger the obligation to provide adequate labeling for that unapproved use. The amended language clarifies that a new intended use is created, and a manufacturer is required to provide adequate labeling on such use, only if the totality of the evidence shows that the manufacturer objectively intends for a drug/device to be used for uncleared/unapproved conditions or purposes.

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