Fox Rothschild LLP

On September 1, 2021, the Food and Drug Administration’s final “intended use” rule will go into effect.  The update is meant to clarify the “intended use” regulations for pharmaceutical products and medical devices.  According to the FDA, this “should reduce manufacturer and stakeholder uncertainty regarding the scenarios in which specific types of evidence may or may not show a product is intended for a drug or device use.”  The updates now provide that a manufacturer’s mere knowledge of an off-label use does not carry with it a new labeling obligation or create new “intended uses.”  However, the FDA can look to “any relevant source” of evidence when determining whether a company intended to market a drug or medical device for off-label use.  You can read more about the FDA’s rule change here.

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