Business · 27/12/2017Updated: 10/17/2026 · 1 min read
FDA Classifies Reagents for Molecular Diagnostic Instrument Test Systems
Summary
The FDA is classifying the reagents for molecular diagnostic instrument test systems into Class I, general controls, to ensure safety and effectiveness, and reduce regulatory burdens, ultimately enhancing patients' access to innovative devices.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →