Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff
Information
Type
Guidance
Regulated products
IVDMD, Medical Devices
Published
August 17, 2022
Last updated
August 16, 2022
Description
This document is a guidance for the industry and FDA staff regarding the replacement reagent and instrument family policy for in vitro diagnostic devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)