Docs of the Month: Knowledge is Not Enough, But it’s a Piece of the Intended Use Puzzle

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FDA’s new proposed rule on “intended use” is meant to calm industry after the agency’s previous go-around with the issue sparked widespread charges of overreach. The new message that a company’s knowledge of off-label use is not sufficient for an enforcement action may indeed be a salve, but the document leaves some questions unanswered.

In the “Docs of the Month” series, we spotlight key items from Pathways’ Document Depot—our running, global inventory of medtech regulatory and policy documents. In this edition: FDA’s recent proposed rule to clarify how it determines a product’s “intended use,” which has important implications for understanding when the agency might look to enforce off-label marketing.

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