{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where docket_id = \"FDA-2023-N-2177\" and posted_year = 2023 sorted by posted_date descending", "rows": [["FDA-2023-N-2177-7194", "FDA", "FDA-2023-N-2177", "Request for Extension from World Marrow Donor Association", "Other", "Request for Extension", "2023-11-27T05:00:00Z", 2023, 11, "2024-11-04T05:00:00Z", null, "2024-11-04T20:43:12Z", null, 0, 0, "09000064862b6bb6"], ["FDA-2023-N-2177-1256", "FDA", "FDA-2023-N-2177", "Request for Extension from American Society for Clinical Pathology", "Other", "Request for Extension", "2023-11-13T05:00:00Z", 2023, 11, "2023-11-13T05:00:00Z", null, "2023-11-13T16:04:55Z", null, 0, 0, "0900006486238c7e"], ["FDA-2023-N-2177-1149", "FDA", "FDA-2023-N-2177", "Response to Request for Comment Period Extension", "Other", "Response(s)", "2023-11-02T04:00:00Z", 2023, 11, "2023-11-02T04:00:00Z", null, "2023-11-02T19:55:26Z", null, 0, 0, "09000064861d8b7d"], ["FDA-2023-N-2177-1135", "FDA", "FDA-2023-N-2177", "Request for Extension from Academy of Clinical Laboratory Physicians and Scientists et al", "Other", "Request for Extension", "2023-10-31T04:00:00Z", 2023, 10, "2023-10-31T04:00:00Z", null, "2023-10-31T18:38:25Z", null, 0, 0, "09000064861a4b16"], ["FDA-2023-N-2177-1130", "FDA", "FDA-2023-N-2177", "Request for Extension from Foundation for the Accreditation of Cellular Therapy", "Other", "Request for Extension", "2023-10-31T04:00:00Z", 2023, 10, "2023-10-31T04:00:00Z", null, "2023-10-31T18:28:19Z", null, 0, 0, "090000648618cc65"], ["FDA-2023-N-2177-1129", "FDA", "FDA-2023-N-2177", "Request for Extension from American Hospital Association", "Other", "Request for Extension", "2023-10-31T04:00:00Z", 2023, 10, "2023-10-31T04:00:00Z", null, "2023-10-31T18:24:43Z", null, 0, 0, "090000648618c3e9"], ["FDA-2023-N-2177-1115", "FDA", "FDA-2023-N-2177", "Request for Extension from American Clinical Laboratory Association", "Other", "Request for Extension", "2023-10-30T04:00:00Z", 2023, 10, "2023-10-30T04:00:00Z", null, "2023-10-30T13:28:44Z", null, 0, 0, "0900006486151c95"], ["FDA-2023-N-2177-1066", "FDA", "FDA-2023-N-2177", "Request for Extension from Coalition for Innovative Laboratory Testing", "Other", "Request for Extension", "2023-10-26T04:00:00Z", 2023, 10, "2023-10-26T04:00:00Z", null, "2023-10-26T14:09:18Z", null, 0, 0, "09000064861080d7"], ["FDA-2023-N-2177-1094", "FDA", "FDA-2023-N-2177", "Request for Extension from American Society for Microbiology", "Other", "Request for Extension", "2023-10-26T04:00:00Z", 2023, 10, "2023-10-26T04:00:00Z", null, "2023-10-26T14:23:31Z", null, 0, 0, "0900006486123f0c"], ["FDA-2023-N-2177-1096", "FDA", "FDA-2023-N-2177", "Request for Extension from American College of Medical Genetics and Genomics", "Other", "Request for Extension", "2023-10-26T04:00:00Z", 2023, 10, "2023-10-26T04:00:00Z", null, "2023-10-26T14:25:17Z", null, 0, 0, "090000648612a070"], ["FDA-2023-N-2177-1098", "FDA", "FDA-2023-N-2177", "Request for Extension from American Red Cross", "Other", "Request for Extension", "2023-10-26T04:00:00Z", 2023, 10, "2023-10-26T04:00:00Z", null, "2023-10-26T14:25:41Z", null, 0, 0, "09000064861374ad"], ["FDA-2023-N-2177-0135", "FDA", "FDA-2023-N-2177", "PRIA Reference 45 - Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-06T04:00:00Z", 2023, 10, null, null, "2023-10-06T15:03:15Z", null, 0, 0, "090000648605809f"], ["FDA-2023-N-2177-0131", "FDA", "FDA-2023-N-2177", "PRIA Reference 14 - Department of Health, Wadsworth Center, \u201cClinical Laboratory Evaluation Program RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-05T04:00:00Z", 2023, 10, null, null, "2023-10-06T15:01:14Z", null, 0, 0, "09000064860501a1"], ["FDA-2023-N-2177-0130", "FDA", "FDA-2023-N-2177", "PRIA Reference 10 - U.S. Government Publishing Office - Laboratory Testing in the Era of Precision Medicine RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-05T04:00:00Z", 2023, 10, null, null, "2023-10-06T15:01:00Z", null, 0, 0, "09000064860501a0"], ["FDA-2023-N-2177-0127", "FDA", "FDA-2023-N-2177", "PRIA Reference 8 - Cheng et al-The clinical and economic impact of inaccurate EGFR mutation tests RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-05T04:00:00Z", 2023, 10, null, null, "2023-10-08T16:35:34Z", null, 0, 0, "090000648604ef5c"], ["FDA-2023-N-2177-0124", "FDA", "FDA-2023-N-2177", "Request for Extension from Association for the Advancement of Blood and Biotherapies (AABB)", "Other", "Request for Extension", "2023-10-05T04:00:00Z", 2023, 10, "2023-10-05T04:00:00Z", null, "2023-10-05T18:00:41Z", null, 0, 0, "090000648603a4ed"], ["FDA-2023-N-2177-0133", "FDA", "FDA-2023-N-2177", "PRIA Reference 16 - Kalorama Information - The Worldwide Market for Laboratory-Developed Tests (LDTs) RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-05T04:00:00Z", 2023, 10, null, null, "2023-10-06T15:01:40Z", null, 0, 0, "0900006486052154"], ["FDA-2023-N-2177-0134", "FDA", "FDA-2023-N-2177", "PRIA Reference 20 - Performance Report to Congress - Medical Device User Fee Amendments FY 2022 RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-05T04:00:00Z", 2023, 10, null, null, "2023-10-08T16:32:47Z", null, 0, 0, "0900006486052155"], ["FDA-2023-N-2177-0121", "FDA", "FDA-2023-N-2177", "Memorandum from Elizabeth Hillebrenner to FDA CDRH", "Other", "Memorandum", "2023-10-05T04:00:00Z", 2023, 10, "2023-10-05T04:00:00Z", null, "2023-10-05T17:06:33Z", null, 0, 0, "090000648604ba44"], ["FDA-2023-N-2177-0128", "FDA", "FDA-2023-N-2177", "PRIA Reference 9 - American Association for Cancer Research - Re Request for Information Regarding 21st Cures RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-05T04:00:00Z", 2023, 10, null, null, "2023-10-06T15:00:32Z", null, 0, 0, "090000648604ee6e"], ["FDA-2023-N-2177-0129", "FDA", "FDA-2023-N-2177", "PRIA Reference 1 - CMS - Clinical Laboratory Improvement Amendments (CLIA) Post-Public Health Emergency (PHE) Guidance RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-05T04:00:00Z", 2023, 10, null, null, "2023-10-06T15:00:49Z", null, 0, 0, "090000648605019f"], ["FDA-2023-N-2177-0132", "FDA", "FDA-2023-N-2177", "PRIA Reference 15 - Congressional Budget Office - Federal Policies in Response to Declining Entrepreneurship RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-05T04:00:00Z", 2023, 10, null, null, "2023-10-06T15:01:27Z", null, 0, 0, "09000064860501a2"], ["FDA-2023-N-2177-0046", "FDA", "FDA-2023-N-2177", "Reference 3 - Congressional Research Service - FDA Regulation of LDTs RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T14:47:12Z", null, 0, 0, "09000064860259b8"], ["FDA-2023-N-2177-0083", "FDA", "FDA-2023-N-2177", "Reference 40 - CMS - Laboratory Developed Tests LDTs Frequently Asked Questions RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T15:54:53Z", null, 0, 0, "09000064860259e0"], ["FDA-2023-N-2177-0090", "FDA", "FDA-2023-N-2177", "Reference 47 - Warning Letter to Inova Genomics Laboratory re MediMap Tests RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T16:04:51Z", null, 0, 0, "09000064860259de"], ["FDA-2023-N-2177-0091", "FDA", "FDA-2023-N-2177", "Reference 48 - Framework for Regulatory Oversight of Laboratory Developed Tests LDTs Draft Guidance RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T16:05:09Z", null, 0, 0, "09000064860259d2"], ["FDA-2023-N-2177-0098", "FDA", "FDA-2023-N-2177", "Reference 55 - Untitled Letter to Navigenics RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T16:09:03Z", null, 0, 0, "0900006486025a00"], ["FDA-2023-N-2177-0101", "FDA", "FDA-2023-N-2177", "Reference 58 - HHS - FAQs on Laboratory Developed Tests LDT RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T16:10:22Z", null, 0, 0, "09000064860259f3"], ["FDA-2023-N-2177-0112", "FDA", "FDA-2023-N-2177", "Reference 69 - It Has Come to Our Attention Letter to MD Biosciences re Zika Virus RNA by RT-PCR Assay RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T16:16:32Z", null, 0, 0, "0900006486025a03"], ["FDA-2023-N-2177-0006", "FDA", "FDA-2023-N-2177", "PRIA Reference 19 - Reportlinker - Laboratory Developed Tests Market Size Share and Trends Analysis Report RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-10T13:34:05Z", null, 0, 0, "090000648601d2a3"], ["FDA-2023-N-2177-0068", "FDA", "FDA-2023-N-2177", "Reference 25 - Rogus and Lurie - FDA Is Letting Harmful Lab-Developed Tests Fall Through the Cracks RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-10T13:56:38Z", null, 0, 0, "09000064860259c9"], ["FDA-2023-N-2177-0080", "FDA", "FDA-2023-N-2177", "Reference 37 - Wang et al. - Challenges and Opportunities for Developing More Generalizable Polygenic Risk Scores RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-10T13:59:53Z", null, 0, 0, "09000064860259ec"], ["FDA-2023-N-2177-0057", "FDA", "FDA-2023-N-2177", "Reference 14 - Vega et al. - Aligning Tumor Mutational Burden Quantification Across Diagnostic Platforms RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-10T13:53:23Z", null, 0, 0, "09000064860259c7"], ["FDA-2023-N-2177-0104", "FDA", "FDA-2023-N-2177", "Reference 61 - Diamond and Lim - Memo Details HHS Push To Upend FDAs Testing Oversight RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-10T14:02:03Z", null, 0, 0, "0900006486025a04"], ["FDA-2023-N-2177-0020", "FDA", "FDA-2023-N-2177", "PRIA Reference 36 - Hopewell et al. - No Impact of KIF6 Genotype on Vascular Risk and Statin Response RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T14:34:51Z", null, 0, 0, "090000648601c64d"], ["FDA-2023-N-2177-0022", "FDA", "FDA-2023-N-2177", "PRIA Reference 38 - Conly et al. - Cost-effectiveness of the use of low- and high-potency statins in people at low cardiovascular risk RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T14:35:37Z", null, 0, 0, "090000648601c65b"], ["FDA-2023-N-2177-0032", "FDA", "FDA-2023-N-2177", "PRIA Reference 49 - I. Eastern Research Group - Economic Analysis of Proposed Revisions to the Good Manufacturing Practices Regulation for Medical Devices Final Report RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T14:41:48Z", null, 0, 0, "090000648601def5"], ["FDA-2023-N-2177-0048", "FDA", "FDA-2023-N-2177", "Reference 5 - Warning Letter to 23andMe re 23andMe Personal Genome Service RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T14:47:52Z", null, 0, 0, "09000064860259aa"], ["FDA-2023-N-2177-0051", "FDA", "FDA-2023-N-2177", "Reference 8 - CDC - Strengthening Clinical Laboratories RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T14:48:53Z", null, 0, 0, "09000064860259a7"], ["FDA-2023-N-2177-0033", "FDA", "FDA-2023-N-2177", "PRIA Reference 50 - I. Eastern Research Group - Economic Analysis of Proposed Revisions to the Good Manufacturing Practices Regulation for Medical Devices Addendum RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T14:42:10Z", null, 0, 0, "090000648601def4"], ["FDA-2023-N-2177-0019", "FDA", "FDA-2023-N-2177", "PRIA Reference 35 - HHS - Valuing COVID-19 Mortality and Morbidity Risk Reductions in U.S. Department of Health and Human Services Regulatory Impact Analyses RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T14:34:23Z", null, 0, 0, "090000648601d2a8"], ["FDA-2023-N-2177-0028", "FDA", "FDA-2023-N-2177", "PRIA Reference 46 - Requirements for Pregnancy and Lactation Labeling Final Regulatory Impact Analysis RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T14:40:19Z", null, 0, 0, "090000648601def2"], ["FDA-2023-N-2177-0035", "FDA", "FDA-2023-N-2177", "PRIA Reference 52 - Microbiology Devices Reclassification of Nucleic Acid-Based Systems for Mycobacterium Tuberculosis Complex Final Regulatory Impact Analysis RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T14:42:52Z", null, 0, 0, "090000648601df16"], ["FDA-2023-N-2177-0027", "FDA", "FDA-2023-N-2177", "PRIA Reference 44 - Agency Information Collection Activities - Reports of Corrections and Removals RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T14:39:55Z", null, 0, 0, "090000648601def1"], ["FDA-2023-N-2177-0002", "FDA", "FDA-2023-N-2177", "PRIA Reference 13 - Memo to File - Information from the NYSDOH for the Preliminary Regulatory Impact Analysis for the LDTs Proposed Rule and Certain Related Analysis RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T14:20:48Z", null, 0, 0, "090000648601d2a1"], ["FDA-2023-N-2177-0041", "FDA", "FDA-2023-N-2177", "PRIA Reference 64 - Gruber - Chapter 2 Public Finance and Public Policy RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-10T13:47:15Z", null, 0, 0, "090000648601df1c"], ["FDA-2023-N-2177-0050", "FDA", "FDA-2023-N-2177", "Reference 7 - Lighthouse Lab Services - Industry Insights RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-10T13:51:40Z", null, 0, 0, "09000064860259a8"], ["FDA-2023-N-2177-0058", "FDA", "FDA-2023-N-2177", "Reference 15 - Offit et al. - Regulation of Laboratory-Developed Tests in Preventive Oncology RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-10T13:53:46Z", null, 0, 0, "09000064860259bc"], ["FDA-2023-N-2177-0055", "FDA", "FDA-2023-N-2177", "Reference 12 - Pfeifer et al. - Reference Samples To Compare Next-Generation Sequencing Test Performance RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-10T13:52:58Z", null, 0, 0, "09000064860259cc"], ["FDA-2023-N-2177-0079", "FDA", "FDA-2023-N-2177", "Reference 36 - Martin et al. - Clinical Use of Current Polygenic Risk Scores May Exacerbate Health Disparities RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-10T13:59:41Z", null, 0, 0, "09000064860259d3"], ["FDA-2023-N-2177-0082", "FDA", "FDA-2023-N-2177", "Reference 39 - Hoskins et al. - Association of Race-Ethnicity and the 21-Gene Recurrence Score With Breast Cancer-Specific Mortality RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-10T14:00:26Z", null, 0, 0, "09000064860259d4"], ["FDA-2023-N-2177-0106", "FDA", "FDA-2023-N-2177", "Reference 63 - Baumann - Virus Testing Push Leaves FDA Lab Oversight in a Bizarre Limbo RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-10T14:02:31Z", null, 0, 0, "09000064860259f4"], ["FDA-2023-N-2177-0077", "FDA", "FDA-2023-N-2177", "Reference 34 - PRIA for LDTs RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T15:52:53Z", null, 0, 0, "09000064860259d7"], ["FDA-2023-N-2177-0075", "FDA", "FDA-2023-N-2177", "Reference 32 - FDA Issues Warning Letter to Genomics Lab for Illegally Marketing Genetic Test RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T15:51:44Z", null, 0, 0, "09000064860259da"], ["FDA-2023-N-2177-0089", "FDA", "FDA-2023-N-2177", "Reference 46 - Letter from Leslie Kux Assistant Commissioner for Policy FDA to Alan Mertz American Clinical Laboratory Association RE: Medical Devices; Laboratory Developed Tests", "Supporting & Related Material", "Background Material", "2023-10-04T04:00:00Z", 2023, 10, null, null, "2023-10-05T16:04:31Z", null, 0, 0, "09000064860259d5"], ["FDA-2023-N-2177-0087", "FDA", "FDA-2023-N-2177", "Reference 44 - Letter from D. Bruce Burlington M.D. Director FDA-CDRH to Jeffrey N. Gibbs Esq. Hyman Phelps  McNamara P.C. 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