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142 rows where docket_id = "FDA-2023-N-2177" and posted_year = 2023 sorted by posted_date descending
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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 |
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