Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular Dystrophy Newborn Screening Test

Document 2025-11796 is a Final Rule published by the Food and Drug Administration in the Federal Register on June 26, 2025, with an effective date of June 26, 2025. The Food and Drug Administration (FDA, the Agency, or we) is classifying the muscular dystrophy newborn screening test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the muscular dystrophy newborn screening test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. View the original at https://www.federalregister.gov/documents/2025/06/26/2025-11796/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-muscular.

No. Document 2025-11796 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.