Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff
Information
Type
Guidance
Regulated products
Medical Devices, Radiation-Emitting Products
Topics
Premarket
Published
February 18, 1998
Last updated
February 28, 2020
Description
This document provides guidance on the procedures for obtaining Class II device exemptions from premarket notification.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)