De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Administrative / Procedural, Premarket
Published
October 5, 2021
Last updated
February 18, 2022
Description
This document is a guidance for the industry and FDA staff on the De Novo classification process for automatic Class III designation evaluation.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)