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.

Organization

Country / Region

United States

License

Other (Public Domain)

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