FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Administrative / Procedural, Premarket
Published
October 3, 2022
Last updated
October 3, 2022
Description
This document provides guidance on FDA and industry actions regarding De Novo classification requests and their impact on review timelines and goals.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)