{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Conducting Remote Regulatory Assessments--Question and Answers.\" The final guidance describes FDA's current thinking regarding its use of remote regulatory assessments (RRAs) and provides answers to frequently asked questions. FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help evaluate compliance of FDA- regulated products with applicable regulatory requirements.","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/2025/06/26/2025-11754.html","cfr_references":[],"citation":"90 FR 27319","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on June 26, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-0810"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-06-26","updated_at":"2025-06-26T09:57:07.929-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-0810-0045","allow_late_comments":false,"id":"FDA-2022-D-0810-0045","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-0810","title":"Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry; Availability"}],"document_number":"2025-11754","effective_on":null,"end_page":27320,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/06/26/2025-11754.xml","html_url":"https://www.federalregister.gov/documents/2025/06/26/2025-11754/conducting-remote-regulatory-assessments-questions-and-answers-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-11754?publication_date=2025-06-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-06-26/2025-11754/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":6099,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-26/pdf/2025-11754.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11754.pdf?1750855513","publication_date":"2025-06-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/06/26/2025-11754.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-D-0810","supporting_documents_count":0,"docket_id":"FDA-2022-D-0810","document_id":"FDA-2022-D-0810-0045","regulation_id_number":null,"title":"Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2025-06-27T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27319,"subtype":null,"title":"Conducting Remote Regulatory Assessments-Questions and Answers; Guidance for Industry; Availability","toc_doc":"Conducting Remote Regulatory AssessmentsQuestions and Answers","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}