Zdrowie i gospodarka · 17/08/2022

FDA Releases Final Guidance on Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices

The Food and Drug Administration (FDA) has released a final guidance document titled 'Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices,' which aims to clarify the application of the policy for manufacturers of in vitro diagnostic devices and FDA staff. The guidance supersedes a previous version issued in 2003, addressing the use of previously cleared assays on new instruments or instrument families.