Recommendations for Dual 510(k) and CLIA Waiver by Application Studies: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Postmarket, Premarket
Published
February 26, 2020
Last updated
January 26, 2021
Description
This document is a guidance document titled "Recommendations for Dual 510(k) and CLIA Waiver by Application Studies" for industry and FDA staff. It covers topics related to postmarket and premarket.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)