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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

8 rows where docket_id = "FDA-2021-N-0507" and posted_year = 2024 sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, posted_date (date), comment_start_date (date), last_modified (date)

document_type 3

  • Supporting & Related Material 5
  • Rule 2
  • Other 1

posted_year 1

  • 2024 · 8 ✖

agency_id 1

  • FDA 8
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2021-N-0507-0089 FDA None FDA-2021-N-0507 Tab A - Final Rule-OMB Original Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:51:49Z   0 0 09000064867fbd15
FDA-2021-N-0507-0090 FDA None FDA-2021-N-0507 Tab A - FRIA-OMB Original Version Supporting & Related Material Background Material 2024-11-04T05:00:00Z 2024 11     2024-11-04T20:51:53Z   0 0 09000064867fbd16
FDA-2021-N-0507-0088 FDA None FDA-2021-N-0507 Memorandum - E.O. 12866: Medical Devices; Quality System Regulation Amendments (Final Rule) Other Memorandum 2024-11-04T05:00:00Z 2024 11 2024-11-04T05:00:00Z   2024-11-04T20:51:41Z   0 0 09000064867fbc68
FDA-2021-N-0507-0087 FDA None FDA-2021-N-0507 Medical Devices; Quality System Regulation Amendments; Correction Rule Correction 2024-10-15T04:00:00Z 2024 10     2024-10-15T14:24:08Z 2024-23701 0 0 09000064867ce682
FDA-2021-N-0507-0083 FDA None FDA-2021-N-0507 Medical Devices; Quality System Regulation Amendments Rule Final Rule 2024-02-02T05:00:00Z 2024 2     2024-02-02T15:49:30Z 2024-01709 0 0 09000064863d7a7f
FDA-2021-N-0507-0085 FDA None FDA-2021-N-0507 Reference 2 - FDA, ‘‘Regulations Establishing Good Manufacturing Practices for the Manufacture, Packing, Storage, and Installation of Medical Devices.’’ Federal Register, 43: 31508–31532, July 21, 1978. Supporting & Related Material Background Material 2024-02-02T05:00:00Z 2024 2     2024-02-03T14:07:40Z   0 0 09000064863d83db
FDA-2021-N-0507-0084 FDA None FDA-2021-N-0507 Reference 1 - ISO 13485:2016, ‘‘Medical devices - Quality management systems -Requirements for regulatory purposes,’’ 3rd Ed., March 1, 2016. Supporting & Related Material Background Material 2024-02-02T05:00:00Z 2024 2     2024-02-03T14:07:18Z   0 0 09000064863d82d7
FDA-2021-N-0507-0086 FDA None FDA-2021-N-0507 Reference 11 - International Standard, ISO 9000 ‘‘Quality Management Systems - Fundamentals and Vocabulary,’’ ISO 9000:2015; 4th Ed., September 15, 2015. (Available at: ISO 9000:2015(en), Quality management systems -Fundamentals Supporting & Related Material Background Material 2024-02-02T05:00:00Z 2024 2     2024-02-03T14:07:53Z   0 0 09000064863d83df

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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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