In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff
Information
Type
Guidance
Regulated products
Biologics, IVDMD, Medical Devices
Topics
Good Clinical Practice (GCP), Premarket
Published
June 25, 2010
Last updated
February 28, 2020
Description
A guidance document providing answers to frequently asked questions about in vitro diagnostic device studies for industry and FDA staff.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)