FDA Issues Final Rule on “Intended Use”

On August 2, 2021, the Food and Drug Administration issued its final rule modifying its regulations on the intended use of medical devices, prescription drugs and biologics. Most importantly, the final rule repeals the 2017 rule’s “knowing clause,” which seemed to imply that a party may be accountable for off-label use if the party “should have known” the product was likely to be used off-label.

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