{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.\" This guidance document provides an overview of the mechanisms available to applicants through which they can request feedback from or a meeting with FDA regarding potential or planned medical device investigational device exemption (IDE) applications, premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, evaluation of automatic class III designations (De Novo requests), premarket notification (510(k)) submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications, Dual 510(k) and CLIA Waiver by Application Submissions, Accessory Classification Requests, and certain investigational new drug (IND) applications and biologics license applications (BLAs).","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/2019/05/07/2019-09338.html","cfr_references":[],"citation":"84 FR 19923","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 7, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-1774"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2019-05-07","updated_at":"2023-06-02T17:56:37.264-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-1774-0013","allow_late_comments":null,"id":"FDA-2018-D-1774-0013","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-1774","title":"Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2019-09338","effective_on":null,"end_page":19925,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/05/07/2019-09338.xml","html_url":"https://www.federalregister.gov/documents/2019/05/07/2019-09338/requests-for-feedback-and-meetings-for-medical-device-submissions-the-q-submission-program-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-09338?publication_date=2019-05-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-05-07/2019-09338/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1378,"last_updated":"2026-08-24 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-05-07/pdf/2019-09338.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-09338.pdf?1557146725","publication_date":"2019-05-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/05/07/2019-09338.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-2018-D-1774","supporting_documents_count":0,"docket_id":"FDA-2018-D-1774","document_id":"FDA-2018-D-1774-0013","regulation_id_number":null,"title":"Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2023-06-03T21:00:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":19923,"subtype":null,"title":"Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":84}