{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with reclassification of medical devices.","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/2021/09/07/2021-19221.html","cfr_references":[],"citation":"86 FR 50132","comment_url":null,"comments_close_on":"2021-11-08","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the collection of information by November 8, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-1529"],"dockets":[{"supporting_documents":[{"title":"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals","document_id":"FDA-2013-N-1529-0029"},{"title":"Agency Information Collection\nActivities; Submission for Office of\nManagement and Budget Review;\nComment Request; Reclassification\nPetitions for Medical Devices","document_id":"FDA-2013-N-1529-0027"},{"title":"Agency Information Collection\nActivities; Submission for Office of\nManagement and Budget Review;\nComment Request; Reclassification\nPetitions for Medical Devices","document_id":"FDA-2013-N-1529-0026"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices","document_id":"FDA-2013-N-1529-0025"},{"title":"04 Reference 3 Final Regulatory Impact Analysis - Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures","document_id":"FDA-2013-N-1529-0024"},{"title":"03 Reference 2 Open Public Hearings Guidance - Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings","document_id":"FDA-2013-N-1529-0023"},{"title":"02 Reference 1 Medical Device Classification Product Codes Guidance for Industry","document_id":"FDA-2013-N-1529-0022"},{"title":"01 Index to References - Final Rule, Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures","document_id":"FDA-2013-N-1529-0021"},{"title":"Medical Device Classification Procedures: Incorporating Food and\nDrug Administration Safety and Innovation Act Procedures","document_id":"FDA-2013-N-1529-0020"},{"title":"Medical Device Classification Procedures; Change of Address; Technical Amendment","document_id":"FDA-2013-N-1529-0019"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2021-09-07","updated_at":"2023-02-28T17:22:39.862-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-N-1529-0025","allow_late_comments":null,"id":"FDA-2013-N-1529-0025","comment_end_date":"2021-11-09","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":13,"id":"FDA-2013-N-1529","title":"Medical Device Classification Procedures"}],"document_number":"2021-19221","effective_on":null,"end_page":50134,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/09/07/2021-19221.xml","html_url":"https://www.federalregister.gov/documents/2021/09/07/2021-19221/agency-information-collection-activities-proposed-collection-comment-request-reclassification","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-19221?publication_date=2021-09-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-09-07/2021-19221/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":765,"last_updated":"2026-10-23 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-09-07/pdf/2021-19221.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-19221.pdf?1630673135","publication_date":"2021-09-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/09/07/2021-19221.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals","document_id":"FDA-2013-N-1529-0029"},{"title":"Agency Information Collection\nActivities; Submission for Office of\nManagement and Budget Review;\nComment Request; Reclassification\nPetitions for Medical Devices","document_id":"FDA-2013-N-1529-0027"},{"title":"Agency Information Collection\nActivities; Submission for Office of\nManagement and Budget Review;\nComment Request; Reclassification\nPetitions for Medical Devices","document_id":"FDA-2013-N-1529-0026"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices","document_id":"FDA-2013-N-1529-0025"},{"title":"04 Reference 3 Final Regulatory Impact Analysis - Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures","document_id":"FDA-2013-N-1529-0024"},{"title":"03 Reference 2 Open Public Hearings Guidance - Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings","document_id":"FDA-2013-N-1529-0023"},{"title":"02 Reference 1 Medical Device Classification Product Codes Guidance for Industry","document_id":"FDA-2013-N-1529-0022"},{"title":"01 Index to References - Final Rule, Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures","document_id":"FDA-2013-N-1529-0021"},{"title":"Medical Device Classification Procedures: Incorporating Food and\nDrug Administration Safety and Innovation Act Procedures","document_id":"FDA-2013-N-1529-0020"},{"title":"Medical Device Classification Procedures; Change of Address; Technical Amendment","document_id":"FDA-2013-N-1529-0019"}],"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-2013-N-1529","supporting_documents_count":13,"docket_id":"FDA-2013-N-1529","document_id":"FDA-2013-N-1529-0025","regulation_id_number":null,"title":"Medical Device Classification Procedures","checked_regulationsdotgov_at":"2023-02-28T22:22:39Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":50132,"subtype":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices","toc_doc":"Reclassification Petitions for Medical Devices","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals:\n","topics":[],"type":"Notice","volume":86}