{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Electronic Submission Template for Medical Device 510(k) Submissions.\" This final guidance is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This guidance document provides further standards for the submission of 510(k)s by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the 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/2022/09/22/2022-20512.html","cfr_references":[],"citation":"87 FR 57910","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on September 22, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-D-0872"],"dockets":[{"supporting_documents":[{"title":"Electronic Submission Template for Medical Device 510(k) Submissions Guidance for Industry","document_id":"FDA-2021-D-0872-0014"},{"title":"Electronic Submission Template for Medical Device 510(k) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability","document_id":"FDA-2021-D-0872-0013"},{"title":"Electronic Submission Template for Medical Device 510(k) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","document_id":"FDA-2021-D-0872-0002"},{"title":"Electronic Submission Template for Medical Device 510(k) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","document_id":"FDA-2021-D-0872-0001"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2022-09-22","updated_at":"2023-02-27T21:08:08.546-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-D-0872-0013","allow_late_comments":null,"id":"FDA-2021-D-0872-0013","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":4,"id":"FDA-2021-D-0872","title":"Electronic Submission Template for Medical Device 510(k) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2022-20512","effective_on":null,"end_page":57912,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/09/22/2022-20512.xml","html_url":"https://www.federalregister.gov/documents/2022/09/22/2022-20512/electronic-submission-template-for-medical-device-510k-submissions-guidance-for-industry-and-food","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-20512?publication_date=2022-09-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-09-22/2022-20512/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2131,"last_updated":"2026-10-25 04:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-09-22/pdf/2022-20512.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-20512.pdf?1663764323","publication_date":"2022-09-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/09/22/2022-20512.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Electronic Submission Template for Medical Device 510(k) Submissions Guidance for Industry","document_id":"FDA-2021-D-0872-0014"},{"title":"Electronic Submission Template for Medical Device 510(k) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability","document_id":"FDA-2021-D-0872-0013"},{"title":"Electronic Submission Template for Medical Device 510(k) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","document_id":"FDA-2021-D-0872-0002"},{"title":"Electronic Submission Template for Medical Device 510(k) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","document_id":"FDA-2021-D-0872-0001"}],"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-2021-D-0872","supporting_documents_count":4,"docket_id":"FDA-2021-D-0872","document_id":"FDA-2021-D-0872-0013","regulation_id_number":null,"title":"Electronic Submission Template for Medical Device 510(k) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2023-02-28T02:08:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":57910,"subtype":null,"title":"Electronic Submission Template for Medical Device 510(k) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Electronic Submission Template for Medical Device 510(k) Submissions","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}