{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the gastrointestinal lesion software detection 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 gastrointestinal lesion software detection 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/2023/01/03/2022-28494.html","cfr_references":[{"chapter":null,"citation_url":null,"part":876,"title":21}],"citation":"88 FR 8","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective January 3, 2023. The classification was applicable on April 9, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-3207"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-01-03","updated_at":"2023-02-25T01:19:29.931-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-3207-0001","allow_late_comments":null,"id":"FDA-2022-N-3207-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-N-3207","title":"Medical Devices; Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion Software Detection System"}],"document_number":"2022-28494","effective_on":"2023-01-03","end_page":10,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/01/03/2022-28494.xml","html_url":"https://www.federalregister.gov/documents/2023/01/03/2022-28494/medical-devices-gastroenterology-urology-devices-classification-of-the-gastrointestinal-lesion","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-28494?publication_date=2023-01-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-01-03/2022-28494/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2427,"last_updated":"2026-04-04 00:15:02 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-01-03/pdf/2022-28494.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-28494.pdf?1672407925","publication_date":"2023-01-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/01/03/2022-28494.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-2022-N-3207","supporting_documents_count":0,"docket_id":"FDA-2022-N-3207","document_id":"FDA-2022-N-3207-0001","regulation_id_number":null,"title":"Medical Devices; Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion Software Detection System","checked_regulationsdotgov_at":"2023-02-25T06:19:29Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":8,"subtype":null,"title":"Medical Devices; Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion Software Detection System","toc_doc":"Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion Software Detection System","toc_subject":"Medical Devices:\n","topics":["Medical devices"],"type":"Rule","volume":88}