documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
13 rows where docket_id = "FDA-2021-N-0507" and posted_year = 2022 sorted by posted_date descending
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Suggested facets: subtype, posted_date, posted_month, posted_date (date), comment_start_date (date), comment_end_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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-0507-0037 | 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;