Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Postmarket, Premarket
Published
August 30, 2019
Last updated
August 29, 2019
Description
This document is a guidance for industry and FDA staff on considering uncertainty in benefit-risk determinations for medical devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)