{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Refuse to Accept Policy for 510(k)s.\" The purpose of this document is to explain the procedures and criteria FDA intends to use in determining whether a 510(k) submission is administratively complete, which determines whether it should be accepted for substantive review and clearance. This guidance is applicable to 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).","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/2013/01/02/2012-31477.html","cfr_references":[],"citation":"78 FR 100","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-2012-D-0523"],"dockets":[],"document_number":"2012-31477","effective_on":null,"end_page":101,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/01/02/2012-31477.xml","html_url":"https://www.federalregister.gov/documents/2013/01/02/2012-31477/guidance-for-industry-and-food-and-drug-administration-staff-refuse-to-accept-policy-for-510ks","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-31477?publication_date=2013-01-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-01-02/2012-31477/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":232,"last_updated":"2026-10-25 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-01-02/pdf/2012-31477.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-31477.pdf?1356962026","publication_date":"2013-01-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/01/02/2012-31477.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-2012-D-0523","supporting_documents_count":0,"docket_id":"FDA-2012-D-0523","regulation_id_number":null,"title":"Draft Guidance for Industry and Food and Drug Administration Staff; Refuse to Accept Policy for 510(k)s; Availability","checked_regulationsdotgov_at":"2013-02-19T17:34:40Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":100,"subtype":null,"title":"Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability","toc_doc":"Refuse to Accept Policy for 510(k)s","toc_subject":"Guidance for Industry and Food and Drug Administration Staff; Availability:","topics":[],"type":"Notice","volume":78}