FDA Drafts Guidance on Replacing Reagents for IVD Devices Post author:Sam Post published:February 15, 2018 Post category:The GMP Letter The FDA issued draft guidance to provide updates on in vitro diagnostics’ replacement reagents. Source: The GMP Letter You Might Also Like 483 Roundup: Six Devicemakers Rapped for Quality Lapses May 12, 2020 Judge Rules Case Against St. Jude Defibrillators Can Go Ahead September 12, 2017 Rhode Island Firm Draws Warning for Design Controls March 6, 2020