Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Premarket
Published
February 8, 2019
Last updated
June 14, 2019
Description
This document is a guidance for the industry and FDA staff regarding the exemption of certain unclassified medical devices from premarket notification requirements.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)