{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the Zika virus serological reagents 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 Zika virus serological reagents' 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/2025/05/29/2025-09639.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"866","title":21}],"citation":"90 FR 22632","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective May 29, 2025. The classification was applicable on May 23, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-1160"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-05-29","updated_at":"2025-05-29T10:56:39.060-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-1160-0001","allow_late_comments":false,"id":"FDA-2025-N-1160-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-N-1160","title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents"}],"document_number":"2025-09639","effective_on":"2025-05-29","end_page":22634,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/05/29/2025-09639.xml","html_url":"https://www.federalregister.gov/documents/2025/05/29/2025-09639/medical-devices-immunology-and-microbiology-devices-classification-of-the-zika-virus-serological","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-09639?publication_date=2025-05-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-05-29/2025-09639/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":226,"last_updated":"2026-10-24 22:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-29/pdf/2025-09639.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-09639.pdf?1748436318","publication_date":"2025-05-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/05/29/2025-09639.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-1160","supporting_documents_count":0,"docket_id":"FDA-2025-N-1160","document_id":"FDA-2025-N-1160-0001","regulation_id_number":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents","checked_regulationsdotgov_at":"2025-05-30T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":22632,"subtype":null,"title":"Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents","toc_doc":"Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents","toc_subject":"Medical Devices","topics":["Biologics","Laboratories","Medical devices"],"type":"Rule","volume":90}