{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"The Special 510(k) Program.\" FDA established the Special 510(k) Program to facilitate the submission, review, and clearance of changes to a manufacturer's own legally marketed predicate device. This draft guidance, when finalized, will provide the framework that FDA will use when considering whether a premarket notification (510(k)) is appropriate for review as a Special 510(k). This draft guidance is not final nor is it in effect at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2018/09/28/2018-21141.html","cfr_references":[],"citation":"83 FR 49097","comment_url":null,"comments_close_on":"2018-11-27","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by November 27, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2018-D-3304"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":13,"comment_start_date":"2018-09-28","updated_at":"2023-03-01T02:56:52.449-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-3304-0001","allow_late_comments":null,"id":"FDA-2018-D-3304-0001","comment_end_date":"2018-11-28","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-3304","title":"The Special 510(k) Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2018-21141","effective_on":null,"end_page":49099,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/09/28/2018-21141.xml","html_url":"https://www.federalregister.gov/documents/2018/09/28/2018-21141/the-special-510k-program-draft-guidance-for-industry-and-food-and-drug-administration-staff","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-21141?publication_date=2018-09-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-09-28/2018-21141/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1866,"last_updated":"2026-04-04 00:15:02 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-09-28/pdf/2018-21141.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-21141.pdf?1538052326","publication_date":"2018-09-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/09/28/2018-21141.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":13,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-3304","supporting_documents_count":0,"docket_id":"FDA-2018-D-3304","document_id":"FDA-2018-D-3304-0001","regulation_id_number":null,"title":"The Special 510(k) Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2023-03-01T07:56:51Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":49097,"subtype":null,"title":"The Special 510(k) Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"The Special 510(k) Program","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}