Business · 26/06/2025Updated: 10/17/2026 · 1 min read
FDA Classifies Lysosomal Storage Disorder Newborn Screening Test System into Class II (Special Controls)
Summary
The FDA has classified the lysosomal storage disorder newborn screening test system into Class II (special controls) to ensure safety and effectiveness, aiming to reduce regulatory burdens and enhance patient access to innovative devices.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →