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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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501 rows where docket_id = "FDA-2023-N-2177" sorted by posted_date descending

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document_type 5

  • Supporting & Related Material 482
  • Other 16
  • Notice 1
  • Proposed Rule 1
  • Rule 1

posted_year 2

  • 2024 359
  • 2023 142

agency_id 1

  • FDA 501
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2177-7203 FDA None FDA-2023-N-2177 Tab A - Final Rule-OMB Original Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:49:09Z   0 0 09000064867fb99f
FDA-2023-N-2177-7208 FDA None FDA-2023-N-2177 Tab C - FRIA-OMB Final Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:49:30Z   0 0 09000064867fb9a4
FDA-2023-N-2177-7199 FDA None FDA-2023-N-2177 Tab A - Proposed Rule-OMB Original Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:44:56Z   0 0 09000064867fbbde
FDA-2023-N-2177-7201 FDA None FDA-2023-N-2177 Tab C - Proposed Rule-OMB Final Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:45:04Z   0 0 09000064867fbc28
FDA-2023-N-2177-7202 FDA None FDA-2023-N-2177 Memorandum - Medical Devices; Laboratory Developed Tests (Final Rule) Other Memorandum 2024-11-04T05:00:00Z 2024 11 2024-11-04T05:00:00Z   2024-11-04T20:49:00Z   0 0 09000064867fba1c
FDA-2023-N-2177-7207 FDA None FDA-2023-N-2177 Tab B - FRIA-Comparison OMB Original to Final Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:49:25Z   0 0 09000064867fb9a3
FDA-2023-N-2177-7206 FDA None FDA-2023-N-2177 Tab A - FRIA-OMB Original Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:49:21Z   0 0 09000064867fb9a2
FDA-2023-N-2177-7204 FDA None FDA-2023-N-2177 Tab B - Final Rule-Comparison OMB Original to Final Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:49:13Z   0 0 09000064867fb9a0
FDA-2023-N-2177-7197 FDA None FDA-2023-N-2177 Tab B - PRIA-Comparision OMB Original to Final Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:44:47Z   0 0 09000064867fbbdc
FDA-2023-N-2177-7195 FDA None FDA-2023-N-2177 Memorandum - Medical Devices; Laboratory Developed Tests (proposed rule) Other Memorandum 2024-11-04T05:00:00Z 2024 11 2024-11-04T05:00:00Z   2024-11-04T20:44:29Z   0 0 09000064867fbc09
FDA-2023-N-2177-7196 FDA None FDA-2023-N-2177 Tab A - PRIA-OMB Original Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:44:43Z   0 0 09000064867fbbdb
FDA-2023-N-2177-7198 FDA None FDA-2023-N-2177 Tab C - PRIA-OMB Final Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:44:51Z   0 0 09000064867fbbdd
FDA-2023-N-2177-7200 FDA None FDA-2023-N-2177 Tab B - Proposed Rule-Comparison OMB Original to Final Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:45:00Z   0 0 09000064867fbbdf
FDA-2023-N-2177-7205 FDA None FDA-2023-N-2177 Tab C - Final Rule-OMB Final Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:49:17Z   0 0 09000064867fb9a1
FDA-2023-N-2177-7192 FDA None FDA-2023-N-2177 Laboratory Developed Tests: Small Entity Compliance Guide; Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Availability Notice Notice of Availability 2024-06-25T04:00:00Z 2024 6 2024-06-25T04:00:00Z   2024-06-25T12:21:21Z 2024-13872 0 0 09000064865c7228
FDA-2023-N-2177-7193 FDA None FDA-2023-N-2177 Laboratory Developed Tests: Small Entity Compliance Guide; Guidance for Laboratory Manufacturers and Food and Drug Administration Staff Other Guidance 2024-06-25T04:00:00Z 2024 6 2024-06-25T04:00:00Z   2025-06-27T09:00:17Z   1 0 09000064865c704f
FDA-2023-N-2177-7129 FDA None FDA-2023-N-2177 FRIA Reference 13 - Hopewell, et al., "No Impact of KIF6 Genotype on Vascular Risk and Statin Response Among 18,348 Randomized Patients in the Heart Protection Study," Journal of the American College of Cardiology Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T20:21:53Z   0 0 090000648652ddcf
FDA-2023-N-2177-7149 FDA None FDA-2023-N-2177 FRIA Reference 33 - Newman-Toker, "Rate of diagnostic errors and serious misdiagnosis-related harms for major vascular events, infections, and cancers: toward a national incidence estimate using the “Big Three”," Diagnosis Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T20:33:05Z   0 0 090000648652e198
FDA-2023-N-2177-7161 FDA None FDA-2023-N-2177 FRIA Reference 45 - Raisi-Estabragh, et al., "Differential Patterns and Outcomes of 20.6 Million Cardiovascular Emergency Department Encounters for Men and Women in the United States" Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T20:45:20Z   0 0 090000648652e2b3
FDA-2023-N-2177-7165 FDA None FDA-2023-N-2177 FRIA Reference 49 - Centers for Disease Control and Prevention, "National Notifiable Diseases Surveillance System. 2019 annual tables of infectious disease data," 2021 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T22:00:19Z   0 0 090000648652e2fe
FDA-2023-N-2177-7182 FDA None FDA-2023-N-2177 FRIA Reference 66 - Gerhard, Fisher, and Feldman, "Genetic Testing for Inherited Cardiac Diseases in Underserved Populations of Non-European Ancestry: Double Disparity" Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T22:05:51Z   0 0 090000648652e410
FDA-2023-N-2177-7162 FDA None FDA-2023-N-2177 FRIA Reference 46 - Hickner, et al., "Primary Care Physicians' Challenges in Ordering Clinical Laboratory Tests and Interpreting Results" Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T21:59:08Z   0 0 090000648652e2b4
FDA-2023-N-2177-7015 FDA None FDA-2023-N-2177 Reference 165 - FDA, “Premarket Approval (PMA) Database” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:30:46Z   0 0 0900006486529f84
FDA-2023-N-2177-7017 FDA None FDA-2023-N-2177 Reference 167 - FDA, “Establishment Registration & Device Listing Database” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:31:05Z   0 0 090000648652a010
FDA-2023-N-2177-7055 FDA None FDA-2023-N-2177 Reference 205 - Comment to the Docket from American Society for Microbiology Re: Docket No. FDA-2023-N-2177 (December 4, 2023) Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:38:48Z   0 0 090000648652d30c
FDA-2023-N-2177-7078 FDA None FDA-2023-N-2177 Reference 228 - “Susceptibility Test Interpretive Criteria Recognized and Listed on the Susceptibility Test Interpretive Web Page; Reopening of a Public Docket; Request for Comments,” 83 FR 8883 (2018) Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:44:36Z   0 0 090000648652d67c
FDA-2023-N-2177-7047 FDA None FDA-2023-N-2177 Reference 197 - FDA, 510(k) Substantial Equivalence Determination Decision Summary, Selux AST System; Model AST Gen 1.0, K211748, Decision Date April 19, 2023 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:37:19Z   0 0 090000648652c8ba
FDA-2023-N-2177-7065 FDA None FDA-2023-N-2177 Reference 215 - Zhang, “Bionano Genomics Keeps Focus on Clinical Applications for Optical Genome Mapping” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:40:30Z   0 0 090000648652d347
FDA-2023-N-2177-7076 FDA None FDA-2023-N-2177 Reference 226 - FDA, “Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling; Guidance for Industry and Food and Drug Administration Staff,” September 29, 2023 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:44:19Z   0 0 090000648652d389
FDA-2023-N-2177-7016 FDA None FDA-2023-N-2177 Reference 166 - FDA, “Device Classification Under Section 513(f)(2)(De Novo) Database” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:30:53Z   0 0 090000648652a00d
FDA-2023-N-2177-7025 FDA None FDA-2023-N-2177 Reference 175 - FDA, “Device Registration and Listing” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:32:51Z   0 0 090000648652a1b9
FDA-2023-N-2177-7040 FDA None FDA-2023-N-2177 Reference 190 - FDA, “Content of Premarket Submissions for Device Software Functions; Guidance for Industry and Food and Drug Administration Staff,” June 14, 2023 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:36:08Z   0 0 090000648652a4d0
FDA-2023-N-2177-7100 FDA None FDA-2023-N-2177 Reference 250 - FDA, “Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Guidance for Industry and FDA Staff,” March 13, 2007 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:48:21Z   0 0 090000648652d7f1
FDA-2023-N-2177-7114 FDA None FDA-2023-N-2177 Reference 264 - FDA, “Oncology Drug Products Used with Certain In Vitro Diagnostics Pilot Program” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:52:05Z   0 0 090000648652d8b0
FDA-2023-N-2177-6906 FDA None FDA-2023-N-2177 Reference 56 - FDA, “510(k) Third Party Review Program; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:09:57Z   0 0 0900006486523e25
FDA-2023-N-2177-6911 FDA None FDA-2023-N-2177 Reference 61 - FDA, “Deciding When to Submit a 510(k) for a Change to an Existing Device; Guidance for Industry and Food and Drug Administration Staff” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:10:48Z   0 0 0900006486528f79
FDA-2023-N-2177-7030 FDA None FDA-2023-N-2177 Reference 180 - FDA, “Labeling: Regulatory Requirements for Medical Devices,” August, 1989 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:34:23Z   0 0 090000648652a20b
FDA-2023-N-2177-7067 FDA None FDA-2023-N-2177 Reference 217 - Martin, et al., “Clinical Use of Current Polygenic Risk Scores May Exacerbate Health Disparities” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:40:45Z   0 0 090000648652d34e
FDA-2023-N-2177-7044 FDA None FDA-2023-N-2177 Reference 194 - FDA, De Novo Decision Summary, The 23andME Personal Genome Service (PGS) Pharmacogenetic Reports, DEN180028, Decision date October 31, 2018 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:36:37Z   0 0 090000648652a4d5
FDA-2023-N-2177-7061 FDA None FDA-2023-N-2177 Reference 211 - FDA, “Deciding When to Submit a 510(k) for a Software Change to an Existing Device; Guidance for Industry and Food and Drug Administration Staff,” October 25, 2017 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:39:59Z   0 0 090000648652d331
FDA-2023-N-2177-7077 FDA None FDA-2023-N-2177 Reference 227 - Simner, et al., “Raising the Bar: Improving Antimicrobial Resistance Detection by Clinical Laboratories by Ensuring Use of Current Breakpoints” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:44:28Z   0 0 090000648652d38a
FDA-2023-N-2177-6863 FDA None FDA-2023-N-2177 Reference 13 - Alliance for a Stronger FDA, “The US Food and Drug Administration: A Cornerstone of America’s Economic Future” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T15:39:57Z   0 0 090000648652057e
FDA-2023-N-2177-6898 FDA None FDA-2023-N-2177 Reference 48 - Health Resources and Services Administration, “Organ Procurement and Transplantation Network, Policies,” Effective as of April 2, 2024 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T15:52:44Z   0 0 0900006486523c23
FDA-2023-N-2177-6914 FDA None FDA-2023-N-2177 Reference 64 - FDA, “Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Guidance for Industry” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:11:25Z   0 0 09000064865291a0
FDA-2023-N-2177-6924 FDA None FDA-2023-N-2177 Reference 74 - CDC, “Clinical Laboratory Improvement Advisory Committee Summary Report,” April 12-13, 2023 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:13:39Z   0 0 090000648652920d
FDA-2023-N-2177-6925 FDA None FDA-2023-N-2177 Reference 75 - FDA, “The Least Burdensome Provisions: Concept and Principles; Guidance for Industry and FDA Staff” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:13:47Z   0 0 090000648652920e
FDA-2023-N-2177-6929 FDA None FDA-2023-N-2177 Reference 79 - Association for Molecular Pathology, “Clinical Practice – Practice Guidelines” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:14:19Z   0 0 0900006486529291
FDA-2023-N-2177-6947 FDA None FDA-2023-N-2177 Reference 97 - FDA, “Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:17:26Z   0 0 0900006486529374
FDA-2023-N-2177-6951 FDA None FDA-2023-N-2177 Reference 101 - Merker, et al., “Proficiency Testing of Standardized Samples Shows Very High Interlaboratory Agreement for Clinical Next-Generation Sequencing–Based Oncology Assays” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:18:18Z   0 0 0900006486529a15
FDA-2023-N-2177-6954 FDA None FDA-2023-N-2177 Reference 104 - Zhang, et al., “An Overview of Characteristics of Clinical Next-Generation Sequencing–Based Testing for Hematologic Malignancies” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:18:40Z   0 0 0900006486529a18
FDA-2023-N-2177-6960 FDA None FDA-2023-N-2177 Reference 110 - Damon, “The COVID Testing Company That Missed 96% of Cases,” ProPublica, May 16, 2022 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:19:25Z   0 0 0900006486529a82
FDA-2023-N-2177-6913 FDA None FDA-2023-N-2177 Reference 63 - International Society of Blood Transfusion, “Red Cell Immunogenetics and Blood Group Terminology” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:11:17Z   0 0 0900006486528f9e
FDA-2023-N-2177-6928 FDA None FDA-2023-N-2177 Reference 78 - College of American Pathologists, “Laboratory Accreditation: Guide to CAP Accreditation,” 2018 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:14:11Z   0 0 0900006486529290
FDA-2023-N-2177-6934 FDA None FDA-2023-N-2177 Reference 84 - Washington State Department of Health, “Medical Test Sites (MTS) State Authority and Responsibilities” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:15:20Z   0 0 09000064865292de
FDA-2023-N-2177-6940 FDA None FDA-2023-N-2177 Reference 90 - Wittrock, et al., “Implementing Responsible Research and Innovation: Organisational and National Conditions” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:16:08Z   0 0 0900006486529351
FDA-2023-N-2177-6972 FDA None FDA-2023-N-2177 Reference 122 - Greely, “The Future of DTC Genomics and the Law” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:21:23Z   0 0 0900006486529c22
FDA-2023-N-2177-6976 FDA None FDA-2023-N-2177 Reference 126 - Merriam-Webster, Contrivance Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:22:27Z   0 0 0900006486529cb7
FDA-2023-N-2177-6983 FDA None FDA-2023-N-2177 Reference 133 - FDA, “Compliance Policy Guide (CPG) Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k))” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:23:27Z   0 0 0900006486529da9
FDA-2023-N-2177-6996 FDA None FDA-2023-N-2177 Reference 146 - FDA, De Novo Decision Summary, Adaptive Biotechnologies ClonoSEQ Assay, DEN170080, Decision Date September 28, 2018 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:25:46Z   0 0 0900006486529eb6
FDA-2023-N-2177-7009 FDA None FDA-2023-N-2177 Reference 159 - FDA, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Draft Guidance,” December 2011 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:28:47Z   0 0 0900006486529efe
FDA-2023-N-2177-6872 FDA None FDA-2023-N-2177 Reference 22 - AdvaMed, “Press Release: In Congressional Testimony, AdvaMed Urges Passage of Diagnostic Regulatory Reform” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T15:45:16Z   0 0 090000648652293c
FDA-2023-N-2177-6890 FDA None FDA-2023-N-2177 Reference 40 - FDA, “Direct-to-Consumer Tests” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T15:49:04Z   0 0 0900006486523a44
FDA-2023-N-2177-6989 FDA None FDA-2023-N-2177 Reference 139 - Merriam-Webster, Distribute Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:24:29Z   0 0 0900006486529e4d
FDA-2023-N-2177-6889 FDA None FDA-2023-N-2177 Reference 39 - Untitled Letter to Navigenics Corp re: the Navigenics Health Compass Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T15:48:44Z   0 0 09000064865239a9
FDA-2023-N-2177-7147 FDA None FDA-2023-N-2177 FRIA Reference 31 - AstuteAnalytica India Pvt. Ltd., "United States Clinical Laboratory Services Market to Generate Revenue of US $125.6 Billion by 2030: Astute Analytica," 13 March 2023 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2025-02-09T08:19:17Z   0 0 090000648652e192
FDA-2023-N-2177-7160 FDA None FDA-2023-N-2177 FRIA Reference 44 - Centers for Disease Control and Prevention, "Heart Disease Facts" Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2025-02-09T08:24:22Z   0 0 090000648652e2b2
FDA-2023-N-2177-6891 FDA None FDA-2023-N-2177 Reference 41 - Untitled Letter to Interleukin Genetics, Inc. Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2025-02-09T08:23:59Z   0 0 0900006486523a81
FDA-2023-N-2177-7155 FDA None FDA-2023-N-2177 FRIA Reference 39 - National Cancer Institute, "Age and Cancer Risk," National Institutes of Health, 5 March 2021 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2025-02-09T08:24:21Z   0 0 090000648652e23f
FDA-2023-N-2177-7148 FDA None FDA-2023-N-2177 FRIA Reference 32 - U.S. Food and Drug Administration, "Performance Report to Congress: Medical Device User Fee Amendments, FY 2022, page 21," 2022 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T20:32:16Z   0 0 090000648652e193
FDA-2023-N-2177-7125 FDA None FDA-2023-N-2177 FRIA Reference 9 - ECRI, "Deep Dive: Laboratory Testing" Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T20:18:48Z   0 0 090000648652dd1f
FDA-2023-N-2177-7134 FDA None FDA-2023-N-2177 FRIA Reference 18 - Centers for Medicare & Medicaid Services, "Clinical Laboratory Improvement Amendments (CLIA) Post-Public Health Emergency (PHE) Guidance," 11 May 2023 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T20:24:56Z   0 0 090000648652ddd5
FDA-2023-N-2177-7136 FDA None FDA-2023-N-2177 FRIA Reference 20 - U.S. Food and Drug Administration, "Memorandum to File from Brittany Schuck Re: Examples of In Vitro Diagnostic Products (IVDs) Offered as Laboratory Developed Tests (LDTs) that Raise Public Health Concerns," 2023 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T20:25:50Z   0 0 090000648652dde2
FDA-2023-N-2177-7128 FDA None FDA-2023-N-2177 FRIA Reference 12 - New York State Department of Health, "Public Comment: Re: Food and Drug Administration Docket No. FDA-2023-N-2177 (88 FR 68006)" Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T20:21:16Z   0 0 090000648652ddcd
FDA-2023-N-2177-7133 FDA None FDA-2023-N-2177 FRIA Reference 17 - Grand View Research, "Laboratory Developed Tests Market Size, Share & Trends Analysis Report By Technology (Immunoassay, Molecular Diagnostics), By Application (Oncology, Nutritional & Metabolic Disease), By Region, And Segment Forecasts, 2023 - 2030," Grand View Research, San Francisco, 2023 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T20:24:26Z   0 0 090000648652ddd3
FDA-2023-N-2177-7118 FDA None FDA-2023-N-2177 FRIA Reference 2 - Rychert, Schmidt, and Genzen, "Laboratory-Developed Tests Account for a Small Minority of Tests Ordered in an Academic Hospital System," American journal of clinical pathology Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T20:13:01Z   0 0 090000648652d8b8
FDA-2023-N-2177-7164 FDA None FDA-2023-N-2177 FRIA Reference 48 - U.S. Department of Health and Human Services, "Contractor Project Report: International Prescription Drug Price Comparisons: Estimates Using 2022 Data" Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T21:59:47Z   0 0 090000648652e2fc
FDA-2023-N-2177-7178 FDA None FDA-2023-N-2177 FRIA Reference 62 - Eastern Research Group, Inc., "Economic Analysis of CDRH Submission Requirements," 2012 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T22:04:50Z   0 0 090000648652e409
FDA-2023-N-2177-7181 FDA None FDA-2023-N-2177 FRIA Reference 65 - U.S. Food and Drug Administration, "Discussion Paper on Laboratory Developed Tests (LDTs)" Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T22:05:30Z   0 0 090000648652e40f
FDA-2023-N-2177-7188 FDA None FDA-2023-N-2177 FRIA Reference 72 - Gruber, "Chapter2," in PublicFinanceandPublicPolicy Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T22:07:30Z   0 0 090000648652e445
FDA-2023-N-2177-7167 FDA None FDA-2023-N-2177 FRIA Reference 51 - Malek, et al., "Delay in Seeking Care for Sexually Transmitted Diseases in Young Men and Women Attending a Public STD Clinic" Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T22:01:01Z   0 0 090000648652e356
FDA-2023-N-2177-7171 FDA None FDA-2023-N-2177 FRIA Reference 55 - McKnight and Hinton, "Tort Costs in America: An Empirical Analysis of Costs and Compensation of the U.S. Tort System" Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T22:02:18Z   0 0 090000648652e391
FDA-2023-N-2177-7045 FDA None FDA-2023-N-2177 Reference 195 - FDA, 510(k) Substantial Equivalence Determination Decision Summary, BD Respiratory Viral Panel (BD RVP) for BD MAX System; BD Respiratory Viral Panel-SCV2 (BD RVP-SCV2) for BD MAX System, K230956, Decision Date July 31, 2023 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:36:46Z   0 0 090000648652c9c4
FDA-2023-N-2177-7059 FDA None FDA-2023-N-2177 Reference 209 - Harpool, “How Academic Medical Centers can Innovate During Tough Times” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:39:30Z   0 0 090000648652d321
FDA-2023-N-2177-7066 FDA None FDA-2023-N-2177 Reference 216 - Gerhard, et al., “Genetic Testing for Inherited Cardiac Diseases in Underserved Populations of Non-European Ancestry: Double Disparity” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:40:38Z   0 0 090000648652d349
FDA-2023-N-2177-7035 FDA None FDA-2023-N-2177 Reference 185 - FDA, “Modifications to Devices Subject to Premarket Approval (PMA)–The PMA Supplement Decision-Making Process; Guidance for Industry and FDA Staff,” December 11, 2008 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:35:27Z   0 0 09000064865298ae
FDA-2023-N-2177-7014 FDA None FDA-2023-N-2177 Reference 164 - FDA, “FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests,” September 29, 2023 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:30:37Z   0 0 0900006486529f83
FDA-2023-N-2177-7022 FDA None FDA-2023-N-2177 Reference 172 - FDA, “Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff,” November 8, 2016 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:32:06Z   0 0 090000648652a165
FDA-2023-N-2177-7049 FDA None FDA-2023-N-2177 Reference 199 - FDA, De Novo Reclassification Order, Helix Laboratory Platform, DEN190035, Decision date December 23, 2020 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:37:34Z   0 0 090000648652d2cd
FDA-2023-N-2177-7052 FDA None FDA-2023-N-2177 Reference 202 - FDA, “Device Master Files” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:38:14Z   0 0 090000648652d2f5
FDA-2023-N-2177-7094 FDA None FDA-2023-N-2177 Reference 244 - FDA, “FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act; Guidance for Industry,” December 16, 2019 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:47:36Z   0 0 090000648652d7a0
FDA-2023-N-2177-7112 FDA None FDA-2023-N-2177 Reference 262 - FDA, “November 29, 2023: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting Announcement” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:51:49Z   0 0 090000648652d88d
FDA-2023-N-2177-7084 FDA None FDA-2023-N-2177 Reference 234 - FDA, “CDRH Proposed Guidances for Fiscal Year 2024 (FY2024)” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:45:35Z   0 0 090000648652d6a0
FDA-2023-N-2177-7088 FDA None FDA-2023-N-2177 Reference 238 - Sichtig, et al., “FDA-ARGOS is a Database with Public Quality-Controlled Reference Genomes for Diagnostic Use and Regulatory Science” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:46:06Z   0 0 090000648652d734
FDA-2023-N-2177-7099 FDA None FDA-2023-N-2177 Reference 249 - FDA, “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff,” July 28, 2014 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:48:14Z   0 0 090000648652d7ec
FDA-2023-N-2177-7054 FDA None FDA-2023-N-2177 Reference 204 - FDA, “Acceptance Review for De Novo Classification Requests; Guidance for Industry and Food and Drug Administration Staff” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:38:29Z   0 0 090000648652d30b
FDA-2023-N-2177-7064 FDA None FDA-2023-N-2177 Reference 214 - Burky, “Simple HealthKit Inks Deal with Walmart to Expand Access to At-Home Tests” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T16:40:23Z   0 0 090000648652d33f
FDA-2023-N-2177-6862 FDA None FDA-2023-N-2177 Reference 12 - Carpenter et al. "Approval Regulation and Endogenous Consumer Confidence: Theory and Analogies to Licensing, Safety, and Financial Regulation" Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T15:39:48Z   0 0 090000648652057d
FDA-2023-N-2177-6868 FDA None FDA-2023-N-2177 Reference 18 - Memorandum to File, RE: Summary of 2020 Assessment of the First 125 EUA Requests from Laboratories for Molecular Diagnostic Tests for SARS-CoV-2 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T15:40:54Z   0 0 0900006486520775
FDA-2023-N-2177-6869 FDA None FDA-2023-N-2177 Reference 19 - Comment to the Docket from New York State Department of Health Re: Docket No. FDA-2023-N-2177 Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T15:41:03Z   0 0 0900006486520776
FDA-2023-N-2177-6871 FDA None FDA-2023-N-2177 Reference 21 - The Pew Charitable Trusts, “Fact Sheet: Americans Support Increased FDA Oversight to Ensure Accuracy of Diagnostic Tests” Supporting & Related Material Background Material 2024-05-06T04:00:00Z 2024 5     2024-05-06T15:42:23Z   0 0 0900006486522845

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    docket_id TEXT REFERENCES dockets(id),
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CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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