{"abstract":"The Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) is announcing its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot (\"TEMPO pilot\"), in connection with the Center for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, to promote access to certain digital health devices while safeguarding patient safety.","action":"Notice.","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/2025/12/08/2025-22190.html","cfr_references":[],"citation":"90 FR 56768","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"FDA is seeking statements of interest for participation in the TEMPO pilot beginning January 2, 2026. See below for instructions on how to submit a statement of interest for participation in the TEMPO pilot.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-6461"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-12-08","updated_at":"2025-12-08T14:55:55.845-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-6461-0001","allow_late_comments":false,"id":"FDA-2025-N-6461-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-N-6461","title":"Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot"}],"document_number":"2025-22190","effective_on":null,"end_page":56770,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/12/08/2025-22190.xml","html_url":"https://www.federalregister.gov/documents/2025/12/08/2025-22190/technology-enabled-meaningful-patient-outcomes-tempo-for-digital-health-devices-pilot","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-22190?publication_date=2025-12-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-12-08/2025-22190/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":4414,"last_updated":"2026-04-04 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-08/pdf/2025-22190.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-22190.pdf?1764942313","publication_date":"2025-12-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/12/08/2025-22190.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-6461","supporting_documents_count":0,"docket_id":"FDA-2025-N-6461","document_id":"FDA-2025-N-6461-0001","regulation_id_number":null,"title":"Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot","checked_regulationsdotgov_at":"2026-03-07T00:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56768,"subtype":null,"title":"Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot","toc_doc":"Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot","toc_subject":null,"topics":[],"type":"Notice","volume":90}