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Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System

FDA-2026-N-5828-0001Rule

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Title: Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System

Posted: Jun 11, 2026
Comment period: Jun 11, 2026 – ?
Agency: Food and Drug Administration (FDA)
FR Doc: 2026-11740
CFR: 21 CFR Part 866
Topics: Public Health Infrastructure & Data

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