Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA Staff

Information

Type

Guidance

Regulated products

Biologics, Drugs, Medical Devices

Topics

Combination Products

Published

January 26, 2022

Last updated

January 28, 2022

Description

This document is a guidance for industry and FDA staff on the principles of premarket pathways for combination products.

Organization

Country / Region

United States

License

Other (Public Domain)

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