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Reagents for IVD Devices Post author:Sam Post published:February 15, 2018 Post category:The GMP Letter The FDA issued draft guidance to provide updates on in vitro diagnostics’ replacement reagents.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: FDA Cites Firms for Quality, Risk Analysis and SOPs December 6, 2018 Covidien Gets Form 483 for Design, Installation Problems February 10, 2017 FDA Seeks Comment on Medical Device Software June 7, 2018