FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval

by Glenn S. Demby | Jan 3, 2020 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to premarket approval in 2019 after issuing just one such warning letter in all of 2018.