{"abstract":"The Food and Drug Administration (FDA) is classifying the Spinal Muscular Atrophy newborn screening test system 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 classification of the Spinal Muscular Atrophy newborn screening test system. We are taking this action because we have determined that classifying the device into class II 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.","action":"Final amendment; final order.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/06/11/2026-11740.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"866","title":21}],"citation":"91 FR 35384","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective June 11, 2026. The classification was applicable on November 9, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-5828"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-06-11","updated_at":"2026-06-11T09:57:48.233-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-5828-0001","allow_late_comments":false,"id":"FDA-2026-N-5828-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-5828","title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System"}],"document_number":"2026-11740","effective_on":"2026-06-11","end_page":35387,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/06/11/2026-11740.xml","html_url":"https://www.federalregister.gov/documents/2026/06/11/2026-11740/medical-devices-immunology-and-microbiology-devices-classification-of-the-spinal-muscular-atrophy","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-11740?publication_date=2026-06-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-06-11/2026-11740/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":454,"last_updated":"2026-07-25 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-11/pdf/2026-11740.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11740.pdf?1781095520","publication_date":"2026-06-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/06/11/2026-11740.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2026-N-5828","supporting_documents_count":0,"docket_id":"FDA-2026-N-5828","document_id":"FDA-2026-N-5828-0001","regulation_id_number":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System","checked_regulationsdotgov_at":"2026-06-12T16:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":35384,"subtype":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System","toc_doc":"Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System","toc_subject":"Medical Devices","topics":["Biologics","Laboratories","Medical devices"],"type":"Rule","volume":91}