Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Adverse Event Reporting, Combination Products, Investigational Device Exemption (IDE), Postmarket, Premarket, Recalls, Safety - Issues, Errors, And Problems
Published
December 27, 2016
Last updated
March 4, 2019
Description
This document provides guidance for industry and FDA staff on factors to consider in medical device availability, compliance, and enforcement decisions.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)