{"abstract":"The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of March 25, 2014. In the proposed rule, FDA requested comments on its proposal to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA), to update its regulations by proposing changes unrelated to the new FDASIA requirements, and to codify the procedures and criteria that apply to classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.","action":"Proposed rule; extension of comment period.","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/2014/06/12/2014-13705.html","cfr_references":[{"chapter":null,"citation_url":null,"part":860,"title":21}],"citation":"79 FR 33711","comment_url":null,"comments_close_on":"2014-03-25","correction_of":null,"corrections":[],"dates":"FDA is extending the comment period on the proposed rule published March 25, 2014 (79 FR 16252). Submit either electronic or written comments by September 22, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-1529"],"dockets":[],"document_number":"2014-13705","effective_on":null,"end_page":33711,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/06/12/2014-13705.xml","html_url":"https://www.federalregister.gov/documents/2014/06/12/2014-13705/medical-device-classification-procedures-extension-of-comment-period","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-13705?publication_date=2014-06-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-06-12/2014-13705/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":291,"last_updated":"2026-10-23 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-06-12/pdf/2014-13705.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-13705.pdf?1402491864","publication_date":"2014-06-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/06/12/2014-13705.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_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","regulation_id_number":null,"title":"Medical Device Classification Procedures","checked_regulationsdotgov_at":"2014-09-23T05:00:27Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":33711,"subtype":null,"title":"Medical Device Classification Procedures; Extension of Comment Period","toc_doc":"Classification Procedures; Extension","toc_subject":"Medical Devices:","topics":[],"type":"Proposed Rule","volume":79}