documents
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)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;