{"abstract":"The Food and Drug Administration (FDA) proposes to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The proposed requirements establish procedures and criteria related to requests for De Novo classification (\"De Novo request\"). These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation, as well as to limit the unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval. The proposed rule, if finalized, would implement the De Novo classification process under the FD&C Act, as enacted by the Food and Drug Administration Modernization Act of 1997 and modified by the Food and Drug Administration Safety and Innovation Act and the 21st Century Cures Act.","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/2018/12/07/2018-26378.html","cfr_references":[{"chapter":null,"citation_url":null,"part":860,"title":21}],"citation":"83 FR 63127","comment_url":null,"comments_close_on":"2019-03-07","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by March 7, 2019. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by January 7, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-0236"],"dockets":[{"supporting_documents":[{"title":"RIA Ref 6 Medical_Devices_Top_Markets_Report RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0054"},{"title":"RIA Ref 5 NAICS 339100 May 2019 BLS OES RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0053"},{"title":"RIA Ref 4 HHS_RIAGuidance RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0052"},{"title":"RIA Ref 2 Preliminary RIA RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0050"},{"title":"RIA Ref 1 Proposed Rule RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0049"},{"title":"Ref 19 - Emergency Use Authorization of Medical Products and Related Authorities RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0048"},{"title":"Ref 17 - User Fees for 513(g) Requests for Information RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0046"},{"title":"Ref 13 - Requests for Feedback and Meetings for Medical Device Submissions - The Q-Submission Program RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0042"},{"title":"Ref 11 - Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0040"},{"title":"Ref 8 - eCopy Program for Medical Device Submissions RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0039"}],"agency_name":"FDA","documents":[{"comment_count":15,"comment_start_date":"2018-12-07","updated_at":"2023-02-28T21:10:03.088-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-N-0236-0001","allow_late_comments":null,"id":"FDA-2018-N-0236-0001","comment_end_date":"2019-03-08","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":38,"id":"FDA-2018-N-0236","title":"Medical Device De Novo Classification Process"}],"document_number":"2018-26378","effective_on":null,"end_page":63146,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/12/07/2018-26378.xml","html_url":"https://www.federalregister.gov/documents/2018/12/07/2018-26378/medical-device-de-novo-classification-process","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-26378?publication_date=2018-12-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-12-07/2018-26378/mods.xml","not_received_for_publication":null,"page_length":20,"page_views":{"count":7619,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-12-07/pdf/2018-26378.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-26378.pdf?1543931125","publication_date":"2018-12-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/12/07/2018-26378.txt","regulation_id_number_info":{"0910-AH53":{"issue":"202104","html_url":"https://www.federalregister.gov/regulations/0910-AH53/medical-device-de-novo-classification-process","title":"Medical Device De Novo Classification Process","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202104&RIN=0910-AH53&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AH53"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"RIA Ref 6 Medical_Devices_Top_Markets_Report RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0054"},{"title":"RIA Ref 5 NAICS 339100 May 2019 BLS OES RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0053"},{"title":"RIA Ref 4 HHS_RIAGuidance RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0052"},{"title":"RIA Ref 2 Preliminary RIA RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0050"},{"title":"RIA Ref 1 Proposed Rule RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0049"},{"title":"Ref 19 - Emergency Use Authorization of Medical Products and Related Authorities RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0048"},{"title":"Ref 17 - User Fees for 513(g) Requests for Information RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0046"},{"title":"Ref 13 - Requests for Feedback and Meetings for Medical Device Submissions - The Q-Submission Program RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0042"},{"title":"Ref 11 - Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0040"},{"title":"Ref 8 - eCopy Program for Medical Device Submissions RE: Medical Device De Novo Classification Process","document_id":"FDA-2018-N-0236-0039"}],"comments_count":15,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-0236","supporting_documents_count":38,"docket_id":"FDA-2018-N-0236","document_id":"FDA-2018-N-0236-0001","regulation_id_number":null,"title":"Medical Device De Novo Classification Process","checked_regulationsdotgov_at":"2023-03-01T02:10:02Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":63127,"subtype":null,"title":"Medical Device De Novo Classification Process","toc_doc":"Medical Device De Novo Classification Process","toc_subject":null,"topics":["Administrative practice and procedure","Medical devices"],"type":"Proposed Rule","volume":83}