{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Laboratory Developed Tests: Small Entity Compliance Guide.\" The laboratory developed tests (LDT) final rule amended FDA's 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. This small entity compliance guide (SECG) is intended to help small entities comply with applicable medical device regulations, consistent with the LDT final rule, including the phasing out of FDA's general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs.","action":"Notice of availability.","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/2024/06/25/2024-13872.html","cfr_references":[],"citation":"89 FR 53109","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on June 25, 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":"2024-06-25","updated_at":"2024-09-03T17:08:09.836-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-2177-7192","allow_late_comments":false,"id":"FDA-2023-N-2177-7192","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":"2024-13872","effective_on":null,"end_page":53110,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/06/25/2024-13872.xml","html_url":"https://www.federalregister.gov/documents/2024/06/25/2024-13872/laboratory-developed-tests-small-entity-compliance-guide-guidance-for-laboratory-manufacturers-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-13872?publication_date=2024-06-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-06-25/2024-13872/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1187,"last_updated":"2026-08-25 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-25/pdf/2024-13872.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-13872.pdf?1719233120","publication_date":"2024-06-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/06/25/2024-13872.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"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. 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"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-N-2177","supporting_documents_count":470,"docket_id":"FDA-2023-N-2177","document_id":"FDA-2023-N-2177-7192","regulation_id_number":null,"title":"Medical Devices; Laboratory Developed Tests","checked_regulationsdotgov_at":"2024-06-26T12:00:24Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":53109,"subtype":null,"title":"Laboratory Developed Tests: Small Entity Compliance Guide; Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Availability","toc_doc":"Laboratory Developed Tests: Small Entity Compliance Guide","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}