documents
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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document_type 4
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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;