User Fees and Refunds for De Novo Classification Requests : Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Administrative / Procedural, Premarket

Published

October 5, 2022

Last updated

October 6, 2022

Description

This document is a guidance for industry and FDA staff on user fees and refunds for de novo classification requests.

Organization

Country / Region

United States

License

Other (Public Domain)

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