Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA Staff
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Combination Products
Published
September 25, 2017
Last updated
May 13, 2021
Description
This document provides guidance for classifying products as drugs and devices, with a focus on combination products.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)