{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is classifying the lysosomal storage disorder 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 the lysosomal storage disorder newborn screening test system'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.","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/2025/06/26/2025-11781.html","cfr_references":[{"chapter":null,"citation_url":null,"part":862,"title":21}],"citation":"90 FR 27229","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective June 26, 2025. The classification was applicable on February 3, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-1447"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-06-26","updated_at":"2025-06-26T10:56:41.424-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-1447-0001","allow_late_comments":false,"id":"FDA-2025-N-1447-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-N-1447","title":"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test System"}],"document_number":"2025-11781","effective_on":"2025-06-26","end_page":27231,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/06/26/2025-11781.xml","html_url":"https://www.federalregister.gov/documents/2025/06/26/2025-11781/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-lysosomal","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-11781?publication_date=2025-06-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-06-26/2025-11781/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":248,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-26/pdf/2025-11781.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11781.pdf?1750855516","publication_date":"2025-06-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/06/26/2025-11781.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-2025-N-1447","supporting_documents_count":0,"docket_id":"FDA-2025-N-1447","document_id":"FDA-2025-N-1447-0001","regulation_id_number":null,"title":"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test System","checked_regulationsdotgov_at":"2025-06-27T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27229,"subtype":null,"title":"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test System","toc_doc":"Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test System","toc_subject":"Medical Devices","topics":["Medical devices"],"type":"Rule","volume":90}