documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
501 rows where docket_id = "FDA-2023-N-2177" sorted by posted_date descending
This data as json, CSV (advanced)
Suggested facets: subtype, posted_date, posted_month, comment_start_date, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)
document_type 5
- Supporting & Related Material 482
- Other 16
- Notice 1
- Proposed Rule 1
- Rule 1
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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 |
Advanced export
JSON shape: default, array, newline-delimited, object
CREATE TABLE documents (
id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT,
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
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;