Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended – Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices: Guidance for Industry and FDA Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Labeling, Postmarket
Published
May 1, 2006
Last updated
February 28, 2020
Description
This document provides guidance for manufacturers on labeling requirements for single-use medical devices to comply with the Medical Device User Fee and Modernization Act.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)