{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Medical Device User Fee Small Business Qualification and Determination Guidance.\" This guidance updates the previous version of the guidance, titled \"Medical Device User Fee Small Business Qualification and Certification Guidance\", issued on August 1, 2018. The guidance includes updates which describe how FDA plans to determine if a small business is experiencing \"financial hardship\" which makes them eligible for a waiver of their registration fee. The guidance details what information FDA intends to review and consider in making this determination.","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/2025/07/31/2025-14460.html","cfr_references":[],"citation":"90 FR 36060","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on July 31, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-1873"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-07-31","updated_at":"2025-07-31T09:56:24.763-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-1873-0010","allow_late_comments":false,"id":"FDA-2018-D-1873-0010","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-1873","title":"Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff, and Foreign Governments"}],"document_number":"2025-14460","effective_on":null,"end_page":36061,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/07/31/2025-14460.xml","html_url":"https://www.federalregister.gov/documents/2025/07/31/2025-14460/medical-device-user-fee-small-business-qualification-and-determination-guidance-final-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-14460?publication_date=2025-07-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-07-31/2025-14460/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":720,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-31/pdf/2025-14460.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14460.pdf?1753879509","publication_date":"2025-07-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/07/31/2025-14460.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-2018-D-1873","supporting_documents_count":0,"docket_id":"FDA-2018-D-1873","document_id":"FDA-2018-D-1873-0010","regulation_id_number":null,"title":"Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff, and Foreign Governments","checked_regulationsdotgov_at":"2025-08-01T16:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":36060,"subtype":null,"title":"Medical Device User Fee Small Business Qualification and Determination Guidance Final Guidance for Industry and Food and Drug Administration Staff and Foreign Governments; Availability","toc_doc":"Medical Device User Fee Small Business Qualification and Determination Guidance","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}