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Is it a drug, device, biologic, or combination product? FDA issues final guidance on classification

20 October 2017

Hogan Lovells

On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device, biological product, or a combination product, entitled “Classification of Products as Drugs and Devices & Additional Product Classification Issues” (Final Guidance).  See 82 FR 44802 (Sept. 26, 2017). 

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