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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

21 rows where docket_id = "FDA-2021-N-0507" sorted by posted_date descending

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

document_type 4

  • Supporting & Related Material 17
  • Rule 2
  • Other 1
  • Proposed Rule 1

posted_year 2

  • 2022 13
  • 2024 8

agency_id 1

  • FDA 21
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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
FDA-2021-N-0507-0037 FDA None FDA-2021-N-0507 11 - Reference 10 - ISO 9000-2015 Supporting & Related Material Background Material 2022-04-19T04:00:00Z 2022 4     2022-04-19T18:04:31Z   0 0 0900006485024712
FDA-2021-N-0507-0030 FDA None FDA-2021-N-0507 06 - Reference 5 - MDSAP-Medical Device Single Audit Program Supporting & Related Material Background Material 2022-04-13T04:00:00Z 2022 4     2022-04-13T15:00:01Z   0 0 090000648501543b
FDA-2021-N-0507-0031 FDA None FDA-2021-N-0507 07 - Reference 6 - Global Harmonization Task Force Guidance Document Supporting & Related Material Background Material 2022-04-13T04:00:00Z 2022 4     2022-04-13T15:01:17Z   0 0 090000648501543c
FDA-2021-N-0507-0032 FDA None FDA-2021-N-0507 08 - Reference 7 - ISO 14971-2019 Supporting & Related Material Background Material 2022-04-13T04:00:00Z 2022 4     2022-04-13T15:02:24Z   0 0 090000648501543f
FDA-2021-N-0507-0029 FDA None FDA-2021-N-0507 05 - Reference 4 - ISO 9001-1994 Supporting & Related Material Background Material 2022-04-13T04:00:00Z 2022 4     2022-04-13T14:58:36Z   0 0 090000648501543e
FDA-2021-N-0507-0025 FDA None FDA-2021-N-0507 01 - List of References Supporting & Related Material Background Material 2022-04-13T04:00:00Z 2022 4     2022-04-13T14:49:47Z   0 0 0900006485015438
FDA-2021-N-0507-0027 FDA None FDA-2021-N-0507 03 - Reference 2 - FR-1978-07-21 Supporting & Related Material Background Material 2022-04-13T04:00:00Z 2022 4     2022-04-13T14:56:23Z   0 0 0900006485015479
FDA-2021-N-0507-0033 FDA None FDA-2021-N-0507 09 - Reference 8 - MDSAP Voluntary Audit Report Pilot 80FR78741 Supporting & Related Material Background Material 2022-04-13T04:00:00Z 2022 4     2022-04-13T15:03:24Z   0 0 090000648501543d
FDA-2021-N-0507-0026 FDA None FDA-2021-N-0507 02 - Reference 1 - ISO 13485-2016 Supporting & Related Material Background Material 2022-04-13T04:00:00Z 2022 4     2022-04-13T14:51:13Z   0 0 0900006485015439
FDA-2021-N-0507-0028 FDA None FDA-2021-N-0507 04 - Reference 3 - ISO 13485-1996 Supporting & Related Material Background Material 2022-04-13T04:00:00Z 2022 4     2022-04-13T14:57:28Z   0 0 090000648501543a
FDA-2021-N-0507-0034 FDA None FDA-2021-N-0507 10 - Reference 9 - International Medical Device Regulators Forum Supporting & Related Material Background Material 2022-04-13T04:00:00Z 2022 4     2022-04-13T15:04:35Z   0 0 09000064850154bf
FDA-2021-N-0507-0035 FDA None FDA-2021-N-0507 12 - Reference 11 - Preliminary Regulatory Impact Analysis Supporting & Related Material Background Material 2022-04-13T04:00:00Z 2022 4     2022-04-13T15:07:32Z   0 0 09000064850154be
FDA-2021-N-0507-0001 FDA None FDA-2021-N-0507 Medical Devices; Quality System Regulation Amendments Proposed Rule Notice of Proposed Rulemaking (NPRM) 2022-02-23T05:00:00Z 2022 2 2022-02-23T05:00:00Z 2022-05-25T03:59:59Z 2022-05-27T01:00:45Z 2022-03227 0 0 0900006484f9d925

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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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