{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date.\" FDA is issuing this guidance to revise its compliance policy regarding the deadline for filing premarket approval (PMA) applications for previously cleared accessories necessary to the operation of automated external defibrillator (AED) systems.","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/2020/10/28/2020-23841.html","cfr_references":[],"citation":"85 FR 68344","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on October 28, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-D-1877"],"dockets":[],"document_number":"2020-23841","effective_on":null,"end_page":68345,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/10/28/2020-23841.xml","html_url":"https://www.federalregister.gov/documents/2020/10/28/2020-23841/necessary-automated-external-defibrillator-accessories-policy-regarding-compliance-date-immediately","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-23841?publication_date=2020-10-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-10-28/2020-23841/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":418,"last_updated":"2026-08-26 18:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-10-28/pdf/2020-23841.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-23841.pdf?1603802732","publication_date":"2020-10-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/10/28/2020-23841.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-2020-D-1877","supporting_documents_count":0,"docket_id":"FDA-2020-D-1877","document_id":"FDA-2020-D-1877-0001","regulation_id_number":null,"title":"Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date; Immediately in Effect Guidance for Industry, Stakeholders, Health Care Professionals, and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2020-10-30T02:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":68344,"subtype":null,"title":"Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date; Immediately in Effect Guidance for Industry, Stakeholders, Health Care Professionals, and Food and Drug Administration Staff; Availability","toc_doc":"Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}