{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Procedures for Meetings of the Medical Devices Advisory Committee.\" The Center for Devices and Radiological Health (CDRH) is issuing this guidance to provide additional information regarding the processes for meetings of the Medical Devices Advisory Committee panels other than the Dispute Resolution Panel (DRP). This guidance describes the general circumstances in which CDRH consults with a panel, the process for exchange of information between CDRH, the members of the panel, industry, and the public, and the conduct of panel meetings. This guidance supplements existing FDA Agency-wide guidance on the conduct of Advisory Committee meetings. This draft guidance is not final nor is it in effect at this time.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human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/2015/04/01/2015-07438.html","cfr_references":[],"citation":"80 FR 17439","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 1, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-0838"],"dockets":[],"document_number":"2015-07438","effective_on":null,"end_page":17440,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/04/01/2015-07438.xml","html_url":"https://www.federalregister.gov/documents/2015/04/01/2015-07438/procedures-for-meetings-of-the-medical-devices-advisory-committee-draft-guidance-for-industry-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-07438?publication_date=2015-04-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-04-01/2015-07438/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":215,"last_updated":"2026-07-27 16:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-04-01/pdf/2015-07438.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-07438.pdf?1427805998","publication_date":"2015-04-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/04/01/2015-07438.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 3 - Panel Review of Premarket Approval Applications #P91-2 (blue book memo) re Procedures for Meetings of the Medical Devices Advisory Committee","document_id":"FDA-2015-D-0838-0017"},{"title":"Reference 2 - Guidance on Amended Procedures for Advisory Panels Meetings re Procedures for Meetings of the Medical Devices Advisory Committee","document_id":"FDA-2015-D-0838-0016"},{"title":"Reference 1 - Charter Medical Devices Advisory Committee re Procedures for Meetings of the Medical Devices Advisory Committee","document_id":"FDA-2015-D-0838-0015"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-0838","supporting_documents_count":3,"docket_id":"FDA-2015-D-0838","regulation_id_number":null,"title":"Procedures for Meetings of the Medical Devices Advisory Committee","checked_regulationsdotgov_at":"2015-06-02T05:00:42Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":17439,"subtype":null,"title":"Procedures for Meetings of the Medical Devices Advisory Committee; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Procedures for Meetings of the Medical Devices Advisory Committee","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}