Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff

FDA is providing final guidance on issues frequently raised in relation to Requests for Designation (RFDs) and other classification activities.  This guidance focuses particularly on cases in which a product may be classified as a drug or device.  Sponsors can contact the Office of Combination Products (OCP) to confirm classification of any products if appropriate classification is unclear or in dispute.  This guidance for Industry and FDA Staff is dated September 2017.

Click to Open Official Publication

Download Resource