Business · 10/03/2005Updated: 10/17/2026 · 1 min read
FDA Classifies Drug Metabolizing Enzyme Genotyping System as Class II Device
Summary
The FDA has classified the Drug Metabolizing Enzyme Genotyping System as a Class II device, requiring special controls to ensure the device's safety and effectiveness, and has published a guidance document to support this classification.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →