{"abstract":"The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, the Food and Drug Administration is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. This phaseout policy includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs. This phaseout policy is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.","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/2024/05/06/2024-08935.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"809","title":21}],"citation":"89 FR 37286","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective July 5, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-2177"],"dockets":[{"supporting_documents":[{"title":"PRIA Reference 14 - Department of Health, Wadsworth Center, “Clinical Laboratory Evaluation Program RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0131"},{"title":"PRIA Reference 10 - U.S. Government Publishing Office - Laboratory Testing in the Era of Precision Medicine RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0130"},{"title":"PRIA Reference 8 - Cheng et al-The clinical and economic impact of inaccurate EGFR mutation tests RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0127"},{"title":"Reference 63 - Baumann - Virus Testing Push Leaves FDA Lab Oversight in a Bizarre Limbo RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0106"},{"title":"Reference 61 - Diamond and Lim - Memo Details HHS Push To Upend FDAs Testing Oversight RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0104"},{"title":"Reference 60 - HHS - Statement by HHS Secretary Xavier Becerra on Withdrawal of HHS Policy on Laboratory-Developed Tests RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0103"},{"title":"Reference 56 - Laboratory Developed Tests RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0099"},{"title":"Reference 47 - Warning Letter to Inova Genomics Laboratory re MediMap Tests RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0090"},{"title":"Reference 46 - Letter from Leslie Kux Assistant Commissioner for Policy FDA to Alan Mertz American Clinical Laboratory Association RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0089"},{"title":"Reference 44 - Letter from D. Bruce Burlington M.D. Director FDA-CDRH to Jeffrey N. Gibbs Esq. Hyman Phelps  McNamara P.C. RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0087"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-05-06","updated_at":"2024-09-03T16:57:50.898-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-2177-6849","allow_late_comments":false,"id":"FDA-2023-N-2177-6849","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":470,"id":"FDA-2023-N-2177","title":"Medical Devices; Laboratory Developed Tests"}],"document_number":"2024-08935","effective_on":"2024-07-05","end_page":37445,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/05/06/2024-08935.xml","html_url":"https://www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests","images":{"ER06MY24.086":{"large":"https://img.federalregister.gov/ER06MY24.086/ER06MY24.086_large.png","medium":"https://img.federalregister.gov/ER06MY24.086/ER06MY24.086_medium.png","original_size":"https://img.federalregister.gov/ER06MY24.086/ER06MY24.086_original_size.png"}},"images_metadata":{"ER06MY24.086":{"large":{"identifier":"ER06MY24.086","content_type":"image/png","size":76472,"width":823,"sha":"cf24e9682be0957f8f4f84a6c131bdb2","url":"https://img.federalregister.gov/ER06MY24.086/ER06MY24.086_large.png","height":1044},"medium":{"identifier":"ER06MY24.086","content_type":"image/png","size":37386,"width":527,"sha":"4f4f8aa53dbdf1fd1f7ffdc3272a7b8a","url":"https://img.federalregister.gov/ER06MY24.086/ER06MY24.086_medium.png","height":668},"original_size":{"identifier":"ER06MY24.086","content_type":"image/png","size":119074,"width":3978,"sha":"762dbd5209a6aa355c7ef84808f38e6f","url":"https://img.federalregister.gov/ER06MY24.086/ER06MY24.086_original_size.png","height":5046}}},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-08935?publication_date=2024-05-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-05-06/2024-08935/mods.xml","not_received_for_publication":null,"page_length":160,"page_views":{"count":29543,"last_updated":"2026-07-27 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08935.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08935.pdf?1714398256","publication_date":"2024-05-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/05/06/2024-08935.txt","regulation_id_number_info":{"0910-AI85":{"issue":"202310","html_url":"https://www.federalregister.gov/regulations/0910-AI85/medical-devices-laboratory-developed-tests","title":"Medical Devices; Laboratory Developed Tests","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&RIN=0910-AI85&operation=OPERATION_EXPORT_XML","priority_category":"Section 3(f)(1) Significant"}},"regulation_id_numbers":["0910-AI85"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"PRIA Reference 14 - Department of Health, Wadsworth Center, “Clinical Laboratory Evaluation Program RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0131"},{"title":"PRIA Reference 10 - U.S. Government Publishing Office - Laboratory Testing in the Era of Precision Medicine RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0130"},{"title":"PRIA Reference 8 - Cheng et al-The clinical and economic impact of inaccurate EGFR mutation tests RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0127"},{"title":"Reference 63 - Baumann - Virus Testing Push Leaves FDA Lab Oversight in a Bizarre Limbo RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0106"},{"title":"Reference 61 - Diamond and Lim - Memo Details HHS Push To Upend FDAs Testing Oversight RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0104"},{"title":"Reference 60 - HHS - Statement by HHS Secretary Xavier Becerra on Withdrawal of HHS Policy on Laboratory-Developed Tests RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0103"},{"title":"Reference 56 - Laboratory Developed Tests RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0099"},{"title":"Reference 47 - Warning Letter to Inova Genomics Laboratory re MediMap Tests RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0090"},{"title":"Reference 46 - Letter from Leslie Kux Assistant Commissioner for Policy FDA to Alan Mertz American Clinical Laboratory Association RE: Medical Devices; Laboratory Developed Tests","document_id":"FDA-2023-N-2177-0089"},{"title":"Reference 44 - Letter from D. 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