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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)

14 rows where docket_id = "FDA-2026-P-10528" sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 12
  • Other 2

posted_year 1

  • 2026 14

agency_id 1

  • FDA 14
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-P-10528-0008 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Reference_07_2024-04-09_Philips_Consent_Decree Supporting & Related Material Background Material 2026-09-10T04:00:00Z 2026 9     2026-09-10T20:01:58Z   0 0 09000064b950b2a0
FDA-2026-P-10528-0007 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Reference_06_2023-02-16_TEC_Opinion Supporting & Related Material Background Material 2026-09-10T04:00:00Z 2026 9     2026-09-10T20:01:50Z   0 0 09000064b950b29f
FDA-2026-P-10528-0011 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Reference_10_2025-04-22_Philips_v_ITC_Final_Judgment Supporting & Related Material Background Material 2026-09-10T04:00:00Z 2026 9     2026-09-10T20:02:06Z   0 0 09000064b950b2a5
FDA-2026-P-10528-0003 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Reference_02_2009-04-30_FDA_Citizen_Petition_FDA-2009-P-0207 Supporting & Related Material Background Material 2026-09-10T04:00:00Z 2026 9     2026-09-10T20:01:32Z   0 0 09000064b95092ac
FDA-2026-P-10528-0009 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Reference_08_2024-05-10_FDA_Remanufacturing_Guidance Supporting & Related Material Background Material 2026-09-10T04:00:00Z 2026 9     2026-09-10T20:02:01Z   0 0 09000064b950b2a1
FDA-2026-P-10528-0010 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Reference_09_2025-01-14_FDA_Installation_Servicing_Response Supporting & Related Material Background Material 2026-09-10T04:00:00Z 2026 9     2026-09-10T20:02:03Z   0 0 09000064b950b2a2
FDA-2026-P-10528-0013 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Reference_12_2026-07-24_LOC_Section_1201_Petition Supporting & Related Material Background Material 2026-09-10T04:00:00Z 2026 9     2026-09-10T20:03:52Z   0 0 09000064b950b3d3
FDA-2026-P-10528-0012 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Reference_11_2026-04-21_Shannon_v_Philips_Case_Record Supporting & Related Material Background Material 2026-09-10T04:00:00Z 2026 9     2026-09-10T20:03:50Z   0 0 09000064b950b3d2
FDA-2026-P-10528-0002 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Acknowledgement Letter from FDA DMB to Marshall R. Shannon Other Acknowledgement Letter/Receipt 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T20:01:09Z   0 0 09000064b94d0869
FDA-2026-P-10528-0004 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Reference_03_2017-10-25_FDA_510k_Software_Changes Supporting & Related Material Background Material 2026-09-10T04:00:00Z 2026 9     2026-09-10T20:01:34Z   0 0 09000064b950b29c
FDA-2026-P-10528-0006 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Reference_05_2021-11-09_FTC_Complaint Supporting & Related Material Background Material 2026-09-10T04:00:00Z 2026 9     2026-09-10T20:01:47Z   0 0 09000064b950b29e
FDA-2026-P-10528-0014 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Reference_13_2026-07-28_Royal_Philips_Q2_2026_Quarterly_Report_SEC Supporting & Related Material Background Material 2026-09-10T04:00:00Z 2026 9     2026-09-10T20:03:54Z   0 0 09000064b950b3d4
FDA-2026-P-10528-0001 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Citizen Petition from Marshall R. Shannon Other Citizen Petition 2026-09-10T04:00:00Z 2026 9 2026-09-10T04:00:00Z   2026-09-10T19:51:15Z   1 0 09000064b94d0868
FDA-2026-P-10528-0005 FDA Requests that the FDA clarify a narrow regulatory boundary: what manufacturer obligations remain when postmarket software, access controls, documentation classifications, or service policies affect functions or information used to install, inspect, test, calibrate, maintain, repair, or return medical devices to service FDA-2026-P-10528 Reference_04_2018-05_FDA_Servicing_Report_Docket_FDA-2018-N-3741 Supporting & Related Material Background Material 2026-09-10T04:00:00Z 2026 9     2026-09-10T20:01:37Z   0 0 09000064b950b29d

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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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