FDA Yields To Pressure, Delays ‘Intended Use’ Rule

The agency has granted a petition from trade groups to delay controversial revisions to its definition of “intended use” for at least one year, and is also gathering comments to guide possible further revisions.

FDA has delayed implementation of proposed changes to its definition of “intended use” by one year in the face of significant stakeholder protest.

A final rule published Jan. 9 would have broadened the definition of “intended use” to what is called the “totality...

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