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Case Detail


In re FDA Drug/Device Classification
On September 19, 2011, WLF filed formal comments with the Food and Drug Administration (FDA), urging it to withdraw its Draft Guidance regarding the classification of drugs and medical devices. WLF argued that the Draft Guidance conflicts with the federal statute that defines what constitutes a “medical device.” WLF noted that the new policy would cause numerous products that were previously classified as medical devices to be reclassified as drugs. WLF also argued that the Draft Guidance violates the Administrative Procedure Act (APA), because all major changes in FDA policy may only be undertaken pursuant to the APA’s formal notice-and-comment rulemaking procedures, not pursuant to informal guidance documents. In general, federal law states that a product should be classified as a “drug” rather than a “device” if its “primary intended purpose” involves a chemical action. FDA’s guidance would greatly expand the meaning of “primary intended purpose.”
Case Status:
Awaiting FDA action.
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