{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].\" This guidance document describes FDA's current review practices for premarket notification (510(k)) submissions by describing in greater detail the regulatory framework, policies, and practices underlying FDA's review of traditional 510(k) submissions. This guidance document does not address the special and abbreviated 510(k) programs. FDA intends to finalize those sections separately.","action":"Notice.","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/2014/07/28/2014-17666.html","cfr_references":[],"citation":"79 FR 43753","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-D-0652"],"dockets":[],"document_number":"2014-17666","effective_on":null,"end_page":43754,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/07/28/2014-17666.xml","html_url":"https://www.federalregister.gov/documents/2014/07/28/2014-17666/the-510k-program-evaluating-substantial-equivalence-in-premarket-notifications-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-17666?publication_date=2014-07-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-07-28/2014-17666/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1174,"last_updated":"2026-06-25 02:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-07-28/pdf/2014-17666.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-17666.pdf?1406292590","publication_date":"2014-07-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/07/28/2014-17666.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-D-0652","supporting_documents_count":0,"docket_id":"FDA-2011-D-0652","regulation_id_number":null,"title":"Draft Guidance for Industry and Food and Drug Administration Staff; The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k); Availability","checked_regulationsdotgov_at":"2014-08-17T06:00:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":43753,"subtype":null,"title":"The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"The 510(k) Program  Evaluating Substantial Equivalence in Premarket Notifications","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":79}