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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

comment_end_date
A FULL UTC INSTANT, not a calendar date, despite the column name: '2026-08-29T03:59:59Z' is 11:59:59 PM EASTERN on 2026-08-28. Federal comment periods close at 11:59:59 PM Eastern, so the UTC calendar date is ONE DAY LATER than the official deadline on every end-of-day close — 444,689 of the 444,690 populated rows (measured 2026-09-06). Convert to America/New_York before presenting a deadline, and compare with julianday(comment_end_date) > julianday('now'): a plain > datetime('now') is a TEXT comparison between two different formats and keeps already-closed dockets matching for up to ~20 hours. The sibling column on open_comments.documents WAS corrected to an Eastern calendar date (queue #498); this one is unchanged and still an instant — the two databases do not agree on grain. (queue #644)
comment_start_date
A FULL UTC INSTANT, not a calendar date, despite the column name — same grain as comment_end_date on this table. Convert to America/New_York before presenting it. (queue #644)

17 rows where docket_id = "FDA-2026-N-8249" sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 16
  • Proposed Rule 1

posted_year 1

  • 2026 17

agency_id 1

  • FDA 17
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2026-N-8249-0013 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 11 - Racial differences in detection rate of bladder cancer using blue light cystoscopy Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:44:41Z   0 0 09000064b94630a0
FDA-2026-N-8249-0017 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 15 - National Cancer Institute Bladder Cancer - Cancer Stat Facts Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:50:10Z   0 0 09000064b94630b4
FDA-2026-N-8249-0006 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 4 - NDA 22555.S005 Approval Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:36:48Z   0 0 09000064b9463099
FDA-2026-N-8249-0009 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 7 - P050027 Summary of Safety and Effectiveness (SSED) Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:39:57Z   0 0 09000064b946309c
FDA-2026-N-8249-0010 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 8 - Efficacy and safety of blue light flexible cystoscopy with hexaminolevulinate Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:41:07Z   0 0 09000064b946309d
FDA-2026-N-8249-0011 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 9 - Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:42:19Z   0 0 09000064b946309e
FDA-2026-N-8249-0012 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 10 - Effectiveness of hexaminolevulinate fluorescence cystoscopy for the diagnosis of Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:43:31Z   0 0 09000064b946309f
FDA-2026-N-8249-0004 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 2 - P050027 Approved Labeling Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:35:02Z   0 0 09000064b94573d5
FDA-2026-N-8249-0007 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 5 - CDRH-2014-2015-Strategic---Priorities Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:37:47Z   0 0 09000064b946309a
FDA-2026-N-8249-0016 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 14 - Efficacy and safety of hexaminolevulinate fluorescence cystoscopy in the diagnosis of bladder cancer Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:49:22Z   0 0 09000064b94630b3
FDA-2026-N-8249-0001 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer Proposed Rule Request for Comment 2026-08-17T04:00:00Z 2026 8 2026-08-17T04:00:00Z 2026-10-17T03:59:59Z 2026-10-13T09:00:41Z 2026-16728 1 0 09000064b9462d5a
FDA-2026-N-8249-0003 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 1 - P050027 Approval Order Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:33:43Z   0 0 09000064b94573d4
FDA-2026-N-8249-0005 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 3 - Oncologic Drugs Advisory Committee Meeting Transcript December 17 2009 Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:35:56Z   0 0 09000064b9463098
FDA-2026-N-8249-0008 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 6 - First-Cohort-of-Results-of-the-2014-2015-Strategic-Priority Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:38:45Z   0 0 09000064b946309b
FDA-2026-N-8249-0002 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 List of References Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:29:38Z   0 0 09000064b94573d3
FDA-2026-N-8249-0014 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 12 - Hexylaminolaevulinate fluorescence cystoscopy in patients previously treated with Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:45:44Z   0 0 09000064b94630a1
FDA-2026-N-8249-0015 FDA Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer FDA-2026-N-8249 Reference 13 - Improved diagnosis and long-term recurrence rate reduction for non-muscle-invasive Supporting & Related Material Background Material 2026-08-17T04:00:00Z 2026 8     2026-08-17T18:48:01Z   0 0 09000064b94630b2

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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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