{"abstract":"The Food and Drug Administration (FDA) has classified an autosomal recessive carrier screening gene mutation detection system into class II (special controls). The special controls that apply to this device are identified in this order and will be part of the codified language for the autosomal recessive carrier screening gene mutation detection system classification. The Agency has classified the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.","action":"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/2015/10/27/2015-27197.html","cfr_references":[{"chapter":null,"citation_url":null,"part":866,"title":21}],"citation":"80 FR 65626","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective October 27, 2015. The classification was applicable February 19, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-3472"],"dockets":[],"document_number":"2015-27197","effective_on":"2015-10-27","end_page":65632,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/10/27/2015-27197.xml","html_url":"https://www.federalregister.gov/documents/2015/10/27/2015-27197/medical-devices-immunology-and-microbiology-devices-classification-of-autosomal-recessive-carrier","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-27197?publication_date=2015-10-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-10-27/2015-27197/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":461,"last_updated":"2026-07-26 00:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-10-27/pdf/2015-27197.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-27197.pdf?1445863553","publication_date":"2015-10-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/10/27/2015-27197.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-3472","supporting_documents_count":null,"docket_id":"FDA-2015-N-3472","regulation_id_number":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System.","checked_regulationsdotgov_at":"2015-11-16T06:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":65626,"subtype":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System","toc_doc":"Immunology and Microbiology Devices; Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System","toc_subject":"Medical Devices:","topics":["Biologics","Laboratories","Medical devices"],"type":"Rule","volume":80}