FDA regularly receives questions from medical product sponsors concerning the classification of their products. We believe that efficient, effective regulation is facilitated by providing guidance on issues frequently raised in relation to Requests for Designation (RFDs) and other classification activities. In addition, providing as much clarity and predictability as possible with respect to product classifications should enable informed planning for product development. Accordingly, we have prepared this guidance to make the Agency’s current thinking concerning certain product classification issues more readily and widely available. 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.
Accordingly, this guidance focuses particularly on cases in which a product may be classified as a drug or device.This guidance also addresses additional issues relating to product classification, including how to obtain classification determinations from FDA for medical products
The guidance finalizes and combines two 2011 draft guidances, Classification of Products as Drugs and Devices & Additional Product Classification Issues and Interpretation of the Term ‘Chemical Action’ in the Definition of Device Under Section 201(h) of the Federal Food, Drug and Cosmetic Act, and details how FDA makes product classification decisions and outlines the request for designation (RFD) process.