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Classification of Products as Drugs and Devices & Additional Product Classification Issues



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While issues have arisen relating to whether a product should be classified as a drug, device, biological product, or combination product, most of these issues have related to whether a product should be classified as either a drug or a device.3 Accordingly, this guidance focuses particularly on cases in which a product4 may be classified as a drug or device.5 This guidance also addresses additional issues relating to product classification, including how to obtain classification determinations from FDA for medical products.

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