Business · 19/10/2018Updated: 10/17/2026 · 1 min read
FDA Classifies Positive Airway Pressure Delivery System as Class II Device with Special Controls
The FDA has classified the positive airway pressure delivery system as a Class II device with special controls, aiming to ensure safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →