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withdrawn,object_id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-2025-N-4622-0016,FDA,FDA-2025-N-4622,Reference 14 - P150047 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:51:58Z,,0,0,09000064b909acb3
FDA-2025-N-4622-0023,FDA,FDA-2025-N-4622,"Reference 21 - FDA, “CDRH Announces Intent to Initiate the Reclassification Process for Most High Risk IVDs,” January 31, 2024",Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:52:27Z,,0,0,09000064b909ad51
FDA-2025-N-4622-0001,FDA,FDA-2025-N-4622,"Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With
a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments",Proposed Rule,Request for Comment,2025-11-25T05:00:00Z,2025,11,2025-11-25T05:00:00Z,2026-01-27T04:59:59Z,2026-01-31T13:10:53Z,2025-21071,0,0,09000064b9098c69
FDA-2025-N-4622-0007,FDA,FDA-2025-N-4622,Reference 5 - P160018 S001 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:51:08Z,,0,0,09000064b909a08a
FDA-2025-N-4622-0011,FDA,FDA-2025-N-4622,Reference 9 - P120014 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:51:29Z,,0,0,09000064b909acad
FDA-2025-N-4622-0002,FDA,FDA-2025-N-4622,List of References,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:50:41Z,,0,0,09000064b9099be9
FDA-2025-N-4622-0021,FDA,FDA-2025-N-4622,Reference 19 - P170019 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:52:20Z,,0,0,09000064b909ad3b
FDA-2025-N-4622-0025,FDA,FDA-2025-N-4622,"Reference 23 - Saiki RK, Scharf S, Faloona F, et al. Enzymatic amplification of beta-globin genomic sequences and restriction site analysis for diagnosis of sickle cell anemia. Science. 1985",Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:52:49Z,,0,0,09000064b909ad54
FDA-2025-N-4622-0028,FDA,FDA-2025-N-4622,"Reference 26 - McCombie WR, McPherson JD, Mardis ER. Next-Generation Sequencing Technologies. Cold Spring Harb Perspect Med. 2019",Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:53:00Z,,0,0,09000064b909ad58
FDA-2025-N-4622-0008,FDA,FDA-2025-N-4622,"Reference 6 - Guidance for Industry and for FDA Reviewers: Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997, issued on August 9, 2000",Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:51:21Z,,0,0,09000064b909a08b
FDA-2025-N-4622-0020,FDA,FDA-2025-N-4622,Reference 18 - P170005 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:52:17Z,,0,0,09000064b909ad39
FDA-2025-N-4622-0026,FDA,FDA-2025-N-4622,"Reference 24 - Bej AK, Mahbubani MH, Atlas RM. Amplification of nucleic acids by polymerase chain reaction (PCR) and other methods and their applications. Crit Rev Biochem Mol Biol. 1991",Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:52:53Z,,0,0,09000064b909ad56
FDA-2025-N-4622-0003,FDA,FDA-2025-N-4622,Reference 1 - In Vitro Companion Diagnostic Devices – Guidance for Industry and Food and Drug Administration Staff,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:50:45Z,,0,0,09000064b9099bec
FDA-2025-N-4622-0015,FDA,FDA-2025-N-4622,Reference 13 - P150044 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:51:45Z,,0,0,09000064b909acb2
FDA-2025-N-4622-0017,FDA,FDA-2025-N-4622,Reference 15 - P160038 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:52:01Z,,0,0,09000064b909ad36
FDA-2025-N-4622-0005,FDA,FDA-2025-N-4622,Reference 3 - P140020 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:50:56Z,,0,0,09000064b909a087
FDA-2025-N-4622-0012,FDA,FDA-2025-N-4622,Reference 10 - P120019 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:51:32Z,,0,0,09000064b909acae
FDA-2025-N-4622-0004,FDA,FDA-2025-N-4622,Reference 2 - P110020 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:50:48Z,,0,0,09000064b909a086
FDA-2025-N-4622-0018,FDA,FDA-2025-N-4622,Reference 16 - P160040 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:52:04Z,,0,0,09000064b909ad37
FDA-2025-N-4622-0027,FDA,FDA-2025-N-4622,"Reference 25 - Saiki RK, Gelfand DH, Stoffel S, et al. Primer-directed enzymatic amplification of DNA with a thermostable DNA polymerase. Science. 1988",Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:52:57Z,,0,0,09000064b909ad57
FDA-2025-N-4622-0024,FDA,FDA-2025-N-4622,"Reference 22 - Curtin, SC, Tejada-Vera, B, Bastian, Deaths: Leading Causes for 2021. National Center for Health Statistics",Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:52:45Z,,0,0,09000064b909ad52
FDA-2025-N-4622-0019,FDA,FDA-2025-N-4622,Reference 17 - P160045 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:52:07Z,,0,0,09000064b909ad38
FDA-2025-N-4622-0010,FDA,FDA-2025-N-4622,Reference 8 - P110030 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:51:27Z,,0,0,09000064b909acac
FDA-2025-N-4622-0009,FDA,FDA-2025-N-4622,Reference 7 - P110027 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:51:24Z,,0,0,09000064b909a08d
FDA-2025-N-4622-0013,FDA,FDA-2025-N-4622,Reference 11 - P120022 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:51:35Z,,0,0,09000064b909acaf
FDA-2025-N-4622-0022,FDA,FDA-2025-N-4622,Reference 20 - P170041 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:52:24Z,,0,0,09000064b909ad3c
FDA-2025-N-4622-0014,FDA,FDA-2025-N-4622,Reference 12 - P140023 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:51:43Z,,0,0,09000064b909acb0
FDA-2025-N-4622-0006,FDA,FDA-2025-N-4622,Reference 4 - P160018 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-11-25T05:00:00Z,2025,11,,,2025-11-25T19:50:59Z,,0,0,09000064b909a089