{"abstract":"The Food and Drug Administration (FDA) is proposing 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). FDA is also proposing changes unrelated to the new FDASIA requirements to update its regulations governing classification and reclassification of medical devices. FDA is taking this action 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.","action":"Proposed rule.","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/2014/03/25/2014-06364.html","cfr_references":[{"chapter":null,"citation_url":null,"part":860,"title":21}],"citation":"79 FR 16252","comment_url":null,"comments_close_on":"2014-06-23","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by June 23, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by April 24, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-1529"],"dockets":[],"document_number":"2014-06364","effective_on":null,"end_page":16265,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/03/25/2014-06364.xml","html_url":"https://www.federalregister.gov/documents/2014/03/25/2014-06364/medical-device-classification-procedures","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-06364?publication_date=2014-03-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-03-25/2014-06364/mods.xml","not_received_for_publication":null,"page_length":14,"page_views":{"count":9883,"last_updated":"2026-09-21 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-03-25/pdf/2014-06364.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-06364.pdf?1395415029","publication_date":"2014-03-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/03/25/2014-06364.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-04-14T06:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":16252,"subtype":null,"title":"Medical Device Classification Procedures","toc_doc":"Medical Device Classification Procedures","toc_subject":null,"topics":["Administrative practice and procedure","Medical devices"],"type":"Proposed Rule","volume":79}