HHS FDA Classifies Spinal Muscular Atrophy Newborn Screening Test System as Class II Device
June 12, 2026
June 12, 2026
WASHINGTON, June 12 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final order classifying the Spinal Muscular Atrophy newborn screening test system as a Class II medical device subject to special controls, a move the agency said will provide reasonable assurance of safety and effectiveness while helping expand access to screening technologies. The order became effective on June 11, 2026, although the classification has been applicable since . . .