Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions: Guidance for Industry and FDA Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Good Clinical Practice (GCP), Premarket
Published
September 13, 2007
Last updated
February 28, 2020
Description
This document is a guidance document titled "Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions: Guidance for Industry and FDA Staff". It covers topics such as Good Clinical Practice (GCP) and Premarket.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)