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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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