FDA Classifies Infant Supine Sleep System as Class II Device With Special Controls
July 01, 2026
July 01, 2026
WASHINGTON, July 1 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified the infant supine sleep system as a class II medical device with special controls nationwide.
The Food and Drug Administration issued a rule classifying infant supine sleep systems into Class II with special controls, establishing regulatory requirements the agency said provide reasonable assurance of safety and effectiveness while reducing regulatory burdens fo . . .
The Food and Drug Administration issued a rule classifying infant supine sleep systems into Class II with special controls, establishing regulatory requirements the agency said provide reasonable assurance of safety and effectiveness while reducing regulatory burdens fo . . .