The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

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



Document Type:
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.

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information