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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

28 rows where docket_id = "FDA-2025-N-4622" sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 27
  • Proposed Rule 1

posted_year 1

  • 2025 28

agency_id 1

  • FDA 28
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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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;
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