On September 26, 2017, FDA announced in a Federal Register notice the availability of the final guidance document, Classification of Products as Drugs and Devices & Additional Product Classification Issues. This guidance provides the Agency’s current thinking on approaches for classifying products as drugs and devices, and on certain additional product classification issues, such as the request for designation (RFD) process. The guidance combines and finalizes two draft guidance documents from 2011:
- Classification of Products as Drugs and Devices and Additional Product Classification Issues (available here), and
- Interpretation of the Term “Chemical Action” in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (available here).