{"abstract":"The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.","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/2017/01/12/2017-00199.html","cfr_references":[{"chapter":null,"citation_url":null,"part":866,"title":21}],"citation":"82 FR 3609","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective February 13, 2017. See further discussion in section IV, \"Implementation Strategy.\"","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-0440"],"dockets":[],"document_number":"2017-00199","effective_on":"2017-02-13","end_page":3619,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/01/12/2017-00199.xml","html_url":"https://www.federalregister.gov/documents/2017/01/12/2017-00199/microbiology-devices-reclassification-of-influenza-virus-antigen-detection-test-systems-intended-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-00199?publication_date=2017-01-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-01-12/2017-00199/mods.xml","not_received_for_publication":null,"page_length":11,"page_views":{"count":17808,"last_updated":"2026-04-17 22:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-01-12/pdf/2017-00199.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-00199.pdf?1484142329","publication_date":"2017-01-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/01/12/2017-00199.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-2014-N-0440","supporting_documents_count":0,"docket_id":"FDA-2014-N-0440","regulation_id_number":null,"title":"Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly with Clinical Specimens","checked_regulationsdotgov_at":"2017-02-01T06:00:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":3609,"subtype":null,"title":"Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens","toc_doc":"Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens","toc_subject":"Microbiology Devices:","topics":["Biologics","Laboratories","Medical devices"],"type":"Rule","volume":82}