{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Cuffless Non-invasive Blood Pressure Measuring Devices--Clinical Performance Testing and Evaluation.\" This draft guidance provides recommendations for clinical performance testing and evaluation to support premarket submissions for cuffless non-invasive blood pressure measuring devices. This draft guidance is not final nor is it for implementation at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2026/01/23/2026-01288.html","cfr_references":[],"citation":"91 FR 2939","comment_url":null,"comments_close_on":"2026-03-24","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by March 24, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-D-0851"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-01-23","updated_at":"2026-01-23T09:56:15.833-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-D-0851-0001","allow_late_comments":false,"id":"FDA-2025-D-0851-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-D-0851","title":"Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2026-01288","effective_on":null,"end_page":2940,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/01/23/2026-01288.xml","html_url":"https://www.federalregister.gov/documents/2026/01/23/2026-01288/cuffless-non-invasive-blood-pressure-measuring-devices-clinical-performance-testing-and-evaluation","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-01288?publication_date=2026-01-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-01-23/2026-01288/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":525,"last_updated":"2026-09-23 02:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01288.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-01288.pdf?1769089521","publication_date":"2026-01-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/01/23/2026-01288.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-D-0851","supporting_documents_count":0,"docket_id":"FDA-2025-D-0851","document_id":"FDA-2025-D-0851-0001","regulation_id_number":null,"title":"Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2026-01-24T18:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":2939,"subtype":null,"title":"Cuffless Non-Invasive Blood Pressure Measuring Devices-Clinical Performance Testing and Evaluation; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Cuffless Non-invasive Blood Pressure Measuring DevicesClinical Performance Testing and Evaluation","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}