User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Premarket
Published
October 5, 2022
Last updated
October 19, 2022
Description
This document provides guidance on user fees and refunds for premarket approval applications and device biologics license applications.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)