Business · 09/05/2025Updated: 10/17/2026 · 1 min read
FDA Classifies Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection
Summary
The FDA has classified the device into Class II, special controls, to ensure safety and effectiveness, aiming to reduce regulatory burdens and enhance access to innovative devices for patients.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →