documents
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28 rows where docket_id = "FDA-2025-N-4622" sorted by posted_date descending
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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;