FDA Classifies Infant Incubator Noise Attenuation System As Class II Device
July 26, 2026
July 26, 2026
WASHINGTON, July 26 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified an active noise attenuation system for infant incubators as a Class II medical device subject to special controls, determining the requirements provide reasonable assurance of safety and effectiveness.
The final order is effective July 27, 2026, while the classification was applicable June 16, 2023, when FDA issued an order following a De Novo request from Invi . . .
The final order is effective July 27, 2026, while the classification was applicable June 16, 2023, when FDA issued an order following a De Novo request from Invi . . .