{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring.\" The enforcement policy described in this guidance applies to modified devices where the original device was a legally marketed, non-invasive remote monitoring device listed in the guidance that measures or detects common physiological parameters and that is used to support patient monitoring. The guidance is intended to describe the enforcement policy for limited modifications to the indications, functionality, or hardware or software of device types in the scope of the guidance without prior submission of a 510(k) where such submission would be required.","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/2023/10/19/2023-23110.html","cfr_references":[],"citation":"88 FR 72080","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on October 19, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-4356"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2023-10-19T12:56:38.255-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-4356-0001","allow_late_comments":null,"id":"FDA-2023-D-4356-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-4356","title":"Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring; Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2023-23110","effective_on":null,"end_page":72082,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/10/19/2023-23110.xml","html_url":"https://www.federalregister.gov/documents/2023/10/19/2023-23110/enforcement-policy-for-non-invasive-remote-monitoring-devices-used-to-support-patient-monitoring","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-23110?publication_date=2023-10-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-10-19/2023-23110/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":427,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-10-19/pdf/2023-23110.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-23110.pdf?1697633241","publication_date":"2023-10-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/10/19/2023-23110.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-2023-D-4356","supporting_documents_count":0,"docket_id":"FDA-2023-D-4356","document_id":"FDA-2023-D-4356-0001","regulation_id_number":null,"title":"Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring; Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2023-10-20T16:00:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":72080,"subtype":null,"title":"Enforcement Policy for Non-Invasive Remote Monitoring Devices Used To Support Patient Monitoring; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}