{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the clozapine 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 clozapine 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.","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/2024/09/16/2024-20895.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"862","title":21}],"citation":"89 FR 75489","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective September 16, 2024. The classification was applicable on April 16, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-4058"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2024-09-16T11:55:57.748-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-4058-0001","allow_late_comments":false,"id":"FDA-2024-N-4058-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-4058","title":"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System"}],"document_number":"2024-20895","effective_on":"2024-09-16","end_page":75491,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/09/16/2024-20895.xml","html_url":"https://www.federalregister.gov/documents/2024/09/16/2024-20895/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-clozapine","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-20895?publication_date=2024-09-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-09-16/2024-20895/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":888,"last_updated":"2026-08-24 00:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-16/pdf/2024-20895.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-20895.pdf?1726231525","publication_date":"2024-09-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/09/16/2024-20895.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-2024-N-4058","supporting_documents_count":0,"docket_id":"FDA-2024-N-4058","document_id":"FDA-2024-N-4058-0001","regulation_id_number":null,"title":"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System","checked_regulationsdotgov_at":"2024-09-17T14:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":75489,"subtype":null,"title":"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System","toc_doc":"Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System","toc_subject":"Medical Devices:\n","topics":["Medical devices"],"type":"Rule","volume":89}