{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also making additional changes unrelated to the FDASIA requirements, to update its regulations governing the classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to the 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":"Final 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/2018/12/17/2018-27015.html","cfr_references":[{"chapter":null,"citation_url":null,"part":860,"title":21}],"citation":"83 FR 64443","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective March 18, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA‐2013-N-1529"],"dockets":[],"document_number":"2018-27015","effective_on":"2019-03-18","end_page":64458,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/12/17/2018-27015.xml","html_url":"https://www.federalregister.gov/documents/2018/12/17/2018-27015/medical-device-classification-procedures-incorporating-food-and-drug-administration-safety-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-27015?publication_date=2018-12-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-12-17/2018-27015/mods.xml","not_received_for_publication":null,"page_length":16,"page_views":{"count":7792,"last_updated":"2026-07-27 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-12-17/pdf/2018-27015.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-27015.pdf?1544708719","publication_date":"2018-12-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/12/17/2018-27015.txt","regulation_id_number_info":{"0910-AH75":{"issue":"201810","html_url":"https://www.federalregister.gov/regulations/0910-AH75/medical-devices-medical-device-classification-procedures-incorporating-fda-safety-and-innovation-act","title":"Medical Devices; Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures ","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201810&RIN=0910-AH75&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH75"],"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":"2019-01-06T11:00:33Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":64443,"subtype":null,"title":"Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures","toc_doc":"Incorporating Food and Drug Administration Safety and Innovation Act Procedures","toc_subject":"Medical Device Classification Procedures:","topics":["Administrative practice and procedure","Medical devices"],"type":"Rule","volume":83}