{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Clinical Decision Support Software.\" This final guidance provides clarity on FDA's oversight of clinical decision support (CDS) software intended for health care professionals with the purpose of describing FDA's regulatory approach to CDS software functions. This guidance clarifies the types of CDS functions that do not meet the definition of a device as amended by the 21st Century Cures Act (Cures Act).","action":"Notice of availability.","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/2022/09/28/2022-20993.html","cfr_references":[],"citation":"87 FR 58810","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on September 28, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-D-6569"],"dockets":[{"supporting_documents":[{"title":"Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff; Final Guidance","document_id":"FDA-2017-D-6569-0114"},{"title":"Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff; Availability","document_id":"FDA-2017-D-6569-0113"},{"title":"Clinical Decision Support Software: Draft Guidance for Industry and Food and Drug Administration Staff","document_id":"FDA-2017-D-6569-0041"},{"title":"Clinical Decision Support Software; Draft Guidance for Industry and Food\nand Drug Administration Staff; Availability","document_id":"FDA-2017-D-6569-0040"},{"title":"Clinical and Patient Decision Support Software Draft Guidance","document_id":"FDA-2017-D-6569-0002"},{"title":"Clinical and Patient Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","document_id":"FDA-2017-D-6569-0001"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2022-09-28","updated_at":"2023-02-27T21:47:07.685-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-D-6569-0113","allow_late_comments":null,"id":"FDA-2017-D-6569-0113","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":6,"id":"FDA-2017-D-6569","title":"Clinical and Patient Decision Support Software"}],"document_number":"2022-20993","effective_on":null,"end_page":58812,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/09/28/2022-20993.xml","html_url":"https://www.federalregister.gov/documents/2022/09/28/2022-20993/clinical-decision-support-software-guidance-for-industry-and-food-and-drug-administration-staff","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-20993?publication_date=2022-09-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-09-28/2022-20993/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":3542,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-09-28/pdf/2022-20993.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-20993.pdf?1664282726","publication_date":"2022-09-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/09/28/2022-20993.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Clinical Decision Support Software; 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Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Clinical Decision Support Software","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}