id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
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,,2024-11-04T20:43:12Z,,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,,2023-11-13T16:04:55Z,,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,,2023-11-02T19:55:26Z,,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,,2023-10-31T18:38:25Z,,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,,2023-10-31T18:28:19Z,,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,,2023-10-31T18:24:43Z,,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,,2023-10-30T13:28:44Z,,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,,2023-10-26T14:09:18Z,,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,,2023-10-26T14:23:31Z,,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,,2023-10-26T14:25:17Z,,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,,2023-10-26T14:25:41Z,,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,,,2023-10-06T15:03:15Z,,0,0,090000648605809f
FDA-2023-N-2177-0131,FDA,FDA-2023-N-2177,"PRIA Reference 14 - Department of Health, Wadsworth Center, “Clinical Laboratory Evaluation Program RE: Medical Devices; Laboratory Developed Tests",Supporting & Related Material,Background Material,2023-10-05T04:00:00Z,2023,10,,,2023-10-06T15:01:14Z,,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,,,2023-10-06T15:01:00Z,,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,,,2023-10-08T16:35:34Z,,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,,2023-10-05T18:00:41Z,,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,,,2023-10-06T15:01:40Z,,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,,,2023-10-08T16:32:47Z,,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,,2023-10-05T17:06:33Z,,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,,,2023-10-06T15:00:32Z,,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,,,2023-10-06T15:00:49Z,,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,,,2023-10-06T15:01:27Z,,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,,,2023-10-05T14:47:12Z,,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,,,2023-10-05T15:54:53Z,,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,,,2023-10-05T16:04:51Z,,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,,,2023-10-05T16:05:09Z,,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,,,2023-10-05T16:09:03Z,,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,,,2023-10-05T16:10:22Z,,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,,,2023-10-05T16:16:32Z,,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,,,2023-10-10T13:34:05Z,,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,,,2023-10-10T13:56:38Z,,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,,,2023-10-10T13:59:53Z,,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,,,2023-10-10T13:53:23Z,,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,,,2023-10-10T14:02:03Z,,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,,,2023-10-05T14:34:51Z,,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,,,2023-10-05T14:35:37Z,,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,,,2023-10-05T14:41:48Z,,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,,,2023-10-05T14:47:52Z,,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,,,2023-10-05T14:48:53Z,,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,,,2023-10-05T14:42:10Z,,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,,,2023-10-05T14:34:23Z,,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,,,2023-10-05T14:40:19Z,,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,,,2023-10-05T14:42:52Z,,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,,,2023-10-05T14:39:55Z,,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,,,2023-10-05T14:20:48Z,,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,,,2023-10-10T13:47:15Z,,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,,,2023-10-10T13:51:40Z,,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,,,2023-10-10T13:53:46Z,,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,,,2023-10-10T13:52:58Z,,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,,,2023-10-10T13:59:41Z,,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,,,2023-10-10T14:00:26Z,,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,,,2023-10-10T14:02:31Z,,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,,,2023-10-05T15:52:53Z,,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,,,2023-10-05T15:51:44Z,,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,,,2023-10-05T16:04:31Z,,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. RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:03:05Z,,0,0,09000064860259dd
FDA-2023-N-2177-0099,FDA,FDA-2023-N-2177,Reference 56 - Laboratory Developed Tests RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:09:27Z,,0,0,09000064860259f2
FDA-2023-N-2177-0103,FDA,FDA-2023-N-2177,Reference 60 - HHS - Statement by HHS Secretary Xavier Becerra on Withdrawal of HHS Policy on Laboratory-Developed Tests RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:12:20Z,,0,0,09000064860259f8
FDA-2023-N-2177-0097,FDA,FDA-2023-N-2177,Reference 54 - Monkeypox mpox and Medical Devices RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:07:53Z,,0,0,09000064860259f7
FDA-2023-N-2177-0114,FDA,FDA-2023-N-2177,Reference 71 - Direct-to-Consumer Tests RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:17:12Z,,0,0,0900006486025a07
FDA-2023-N-2177-0116,FDA,FDA-2023-N-2177,Reference 73 - Untitled Letter to Pathway Genomics Inc RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:23:10Z,,0,0,0900006486025a0b
FDA-2023-N-2177-0007,FDA,FDA-2023-N-2177,PRIA Reference 21 - Haileamlak - Pandemics Will be More Frequent RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-08T15:23:38Z,,0,0,090000648601c644
FDA-2023-N-2177-0120,FDA,FDA-2023-N-2177,Reference 77 - 510k Third Party Review Program RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:24:44Z,,0,0,0900006486025a06
FDA-2023-N-2177-0118,FDA,FDA-2023-N-2177,Reference 75 - Transcript of the Molecular and Clinical Genetics Panel Meeting March 9 2011 RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:23:55Z,,0,0,0900006486025a09
FDA-2023-N-2177-0111,FDA,FDA-2023-N-2177,Reference 68 - Government Accountability Office - COVID-19 - FDA Took Steps to Help Make Tests Available Policy for Future Public Health Emergencies Needed RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:16:05Z,,0,0,09000064860259fe
FDA-2023-N-2177-0012,FDA,FDA-2023-N-2177,PRIA Reference 26 - National Cancer Institute - Cancer Stat Facts Common Cancer Sites RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T14:25:32Z,,0,0,090000648601d2a6
FDA-2023-N-2177-0015,FDA,FDA-2023-N-2177,PRIA Reference 29 - Wao et al. - Survival of patients with non-small cell lung cancer without treatment RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T14:27:00Z,,0,0,090000648601c648
FDA-2023-N-2177-0013,FDA,FDA-2023-N-2177,PRIA Reference 27 - National Cancer Institute - Age and Cancer Risk RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T14:25:54Z,,0,0,090000648601d2a7
FDA-2023-N-2177-0043,FDA,FDA-2023-N-2177,PRIA Reference 67 - Hammitt and Liu - Effects of Disease Type and Latency on the Value of Mortality Risk RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T14:45:38Z,,0,0,090000648601df1a
FDA-2023-N-2177-0072,FDA,FDA-2023-N-2177,Reference 29 - Ovarian Cancer Screening Tests - Safety Communication - FDA Recommends Against Use RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T15:45:14Z,,0,0,09000064860259ba
FDA-2023-N-2177-0029,FDA,FDA-2023-N-2177,PRIA Reference 42 - Vyberg et al. - Immunohistochemical expression of HER2 in breast cancer - socioeconomic impact of inaccurate tests RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T14:40:47Z,,0,0,090000648601c65c
FDA-2023-N-2177-0031,FDA,FDA-2023-N-2177,PRIA Reference 48 - Drlik - How Much Does it Cost to Develop a Medical Device RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T14:41:29Z,,0,0,090000648601c65e
FDA-2023-N-2177-0102,FDA,FDA-2023-N-2177,Reference 59 - Memorandum to File - Withdrawal of August 2020 Policy Regarding Laboratory-Developed Tests RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:11:12Z,,0,0,09000064860259f0
FDA-2023-N-2177-0025,FDA,FDA-2023-N-2177,PRIA Reference 41 - McKnight and Hinton - Tort Costs in America - An Empirical Analysis of Costs and Compensation of the U.S. Tort System RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-10T13:41:21Z,,0,0,090000648601deef
FDA-2023-N-2177-0052,FDA,FDA-2023-N-2177,Reference 9 - Ackerman et al. - The Promise and Peril of Precision Medicine RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-10T13:52:06Z,,0,0,09000064860259b6
FDA-2023-N-2177-0061,FDA,FDA-2023-N-2177,Reference 18 - Shuren and Stenzel - Covid-19 Molecular Diagnostic Testing--Lessons Learned RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-10T13:54:44Z,,0,0,09000064860259c8
FDA-2023-N-2177-0044,FDA,FDA-2023-N-2177,Reference 1 - Grand View Research - 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,,,2023-10-05T14:46:32Z,,0,0,09000064860259a5
FDA-2023-N-2177-0084,FDA,FDA-2023-N-2177,Reference 41 - U.S. System of Oversight of Genetic Testing A Response to the Charge of the Secretary of Health and Human Services RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-09T22:14:40Z,,0,0,09000064860259ed
FDA-2023-N-2177-0110,FDA,FDA-2023-N-2177,Reference 67 - Compliance Program Guidance Manual 7342.002 Inspection of Source Plasma Establishments Brokers Testing Laboratories and Contractors RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-09T23:44:48Z,,0,0,09000064860259fc
FDA-2023-N-2177-0011,FDA,FDA-2023-N-2177,PRIA Reference 25 - Newman-Toker et al. - Rate of diagnostic errors and serious misdiagnosis-related harms RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-08T15:31:26Z,,0,0,090000648601c646
FDA-2023-N-2177-0109,FDA,FDA-2023-N-2177,Reference 66 - Compliance Program Guidance Manual 7341.002 Inspection of Human Cells Tissues and Cellular and Tissue-Based Products (HCTPs) RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:15:23Z,,0,0,09000064860259f1
FDA-2023-N-2177-0010,FDA,FDA-2023-N-2177,PRIA Reference 24 - Newman-Toker et al. - Burden of serious harms from diagnostic error in the USA RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T14:24:41Z,,0,0,090000648601c645
FDA-2023-N-2177-0076,FDA,FDA-2023-N-2177,Reference 33 - Memorandum to File - Examples of IVDs Offered as LDTs that Raise Public Health Concerns RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T15:52:12Z,,0,0,09000064860259d8
FDA-2023-N-2177-0018,FDA,FDA-2023-N-2177,PRIA Reference 34 - Robinson Eber and Hammit - Valuing COVID-19 morbidity risk reductions RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T14:34:03Z,,0,0,090000648601c64c
FDA-2023-N-2177-0100,FDA,FDA-2023-N-2177,Reference 57 - HHS - Rescission of Guidances and Other Informal Issuances RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:09:48Z,,0,0,09000064860259f5
FDA-2023-N-2177-0096,FDA,FDA-2023-N-2177,Reference 53 - It Has Come to Our Attention Letter to Texas Childrens Hospital and Houston Methodist Hospital re Zika Direct Test RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:07:13Z,,0,0,09000064860259ff
FDA-2023-N-2177-0095,FDA,FDA-2023-N-2177,Reference 52 - Policy for Coronavirus Disease-2019 Tests Revised Guidance RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-05T16:06:52Z,,0,0,09000064860259ee
FDA-2023-N-2177-0017,FDA,FDA-2023-N-2177,PRIA Reference 33 - Paltiel Zheng and Walensky - Assessment of SARS-CoV-2 screening strategies to permit the safe reopening of college campuses RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-08T15:41:38Z,,0,0,090000648601c64b
FDA-2023-N-2177-0005,FDA,FDA-2023-N-2177,PRIA Reference 18 - AstuteAnalytica India Pvt. Ltd. - United States Clinical Laboratory Services Market RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-10T13:33:42Z,,0,0,090000648601d2a0
FDA-2023-N-2177-0023,FDA,FDA-2023-N-2177,PRIA Reference 39 - Blue Cross and Blue Shield of Minnesota Files Lawsuit Against GS Labs RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-10T13:38:06Z,,0,0,090000648601deed
FDA-2023-N-2177-0053,FDA,FDA-2023-N-2177,Reference 10 - Begley - Genetic Testing Fumbles Revealing Dark Side of Precision Medicine RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-10T13:52:22Z,,0,0,09000064860259a9
FDA-2023-N-2177-0063,FDA,FDA-2023-N-2177,Reference 20 - Clark - For a Host of Vital Lab Tests No FDA Oversight Exists RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-10T13:55:08Z,,0,0,09000064860259bb
FDA-2023-N-2177-0065,FDA,FDA-2023-N-2177,Reference 22 - Kliff and Bhatia - When They Warn of Rare Disorders These Prenatal Tests Are Usually Wrong RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-10T13:55:42Z,,0,0,09000064860259be
FDA-2023-N-2177-0066,FDA,FDA-2023-N-2177,Reference 23 - Robinson Carter and Brindley - The Changing Regulatory Landscape for Laboratory Developed Tests RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-10T13:55:59Z,,0,0,09000064860259c3
FDA-2023-N-2177-0045,FDA,FDA-2023-N-2177,Reference 2 - Pew Charitable Trusts - The Role of Lab-Developed Tests in the In Vitro Diagnostics Market RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-10T13:51:05Z,,0,0,09000064860259b7
FDA-2023-N-2177-0030,FDA,FDA-2023-N-2177,PRIA Reference 47 - Batavia and Goldenberg - Strategic Planning and Costs of FDA Regulation RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-08T17:14:40Z,,0,0,090000648601c65d
FDA-2023-N-2177-0094,FDA,FDA-2023-N-2177,Reference 51 - Policy for Monkeypox Tests To Address the Public Health Emergency Guidance RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-09T22:29:53Z,,0,0,09000064860259fa
FDA-2023-N-2177-0085,FDA,FDA-2023-N-2177,Reference 42 - American Cancer Society Cancer Action Network - Administration Declines to Issue FDA Guidance on LDT Oversight RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-10T14:00:52Z,,0,0,09000064860259cf
FDA-2023-N-2177-0086,FDA,FDA-2023-N-2177,Reference 43 - Advanced Medical Technology Association - AdvaMed Statement on HHS Reversal of LDT Rescission Notice RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-10T14:01:03Z,,0,0,09000064860259df
FDA-2023-N-2177-0108,FDA,FDA-2023-N-2177,Reference 65 - Fortune 500 - The Largest Companies in the U.S. by Revenue RE: Medical Devices; Laboratory Developed Tests,Supporting & Related Material,Background Material,2023-10-04T04:00:00Z,2023,10,,,2023-10-10T14:03:08Z,,0,0,09000064860259ef