Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Adverse Event Reporting, Postmarket
Published
November 8, 2016
Last updated
February 9, 2019
Description
This document provides guidance for manufacturers and FDA staff on adverse event reporting and postmarket surveillance for medical devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)