documents
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13 rows where docket_id = "FDA-2018-N-0628" sorted by posted_date descending
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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, open_for_comment, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)
document_type 4
agency_id 1
- FDA 13
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2018-N-0628-0031 | FDA | None FDA-2018-N-0628 | eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff | Other | Guidance | 2025-12-03T05:00:00Z | 2025 | 12 | 2025-12-03T05:00:00Z | 2025-12-04T02:12:16Z | 0 | 0 | 09000064b90ad119 | ||
| FDA-2018-N-0628-0030 | FDA | None FDA-2018-N-0628 | Memorandum of Meeting from Ster-O-Wave LLC | Other | Memorandum | 2021-08-12T04:00:00Z | 2021 | 8 | 2022-01-24T05:00:00Z | 2022-01-24T10:22:41Z | 0 | 0 | 0900006484f31faa | ||
| FDA-2018-N-0628-0025 | FDA | None FDA-2018-N-0628 | 07- Final Rule Reference Full FRIA 508 | Supporting & Related Material | Background Material | 2019-12-19T05:00:00Z | 2019 | 12 | 2019-12-19T15:00:15Z | 0 | 0 | 09000064842367ca | |||
| FDA-2018-N-0628-0023 | FDA | None FDA-2018-N-0628 | 05 - Final Rule Reference 2 About Electronic Submission Gateway | Supporting & Related Material | Background Material | 2019-12-17T05:00:00Z | 2019 | 12 | 2019-12-17T20:10:15Z | 0 | 0 | 0900006484221abb | |||
| FDA-2018-N-0628-0022 | FDA | None FDA-2018-N-0628 | 04 - Final Rule Reference 1 eCopy Final Guidance | Supporting & Related Material | Background Material | 2019-12-17T05:00:00Z | 2019 | 12 | 2019-12-17T20:08:16Z | 0 | 0 | 0900006484221759 | |||
| FDA-2018-N-0628-0024 | FDA | None FDA-2018-N-0628 | 06 - Final Rule Reference 3 Least Burdensome Provisions | Supporting & Related Material | Background Material | 2019-12-17T05:00:00Z | 2019 | 12 | 2019-12-17T20:12:55Z | 0 | 0 | 0900006484221abc | |||
| FDA-2018-N-0628-0021 | FDA | None FDA-2018-N-0628 | Guidance for eCopy Program for Medical Device Submissions (2019) | Other | 2019-12-17T00:00:00Z | 2019 | 12 | 2024-11-12T23:15:02Z | 0 | 1 | 090000648421e455 | ||||
| FDA-2018-N-0628-0020 | FDA | None FDA-2018-N-0628 | Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format | Rule | Final Rule | 2019-12-16T05:00:00Z | 2019 | 12 | 2019-12-16T05:00:00Z | 2019-12-16T16:22:23Z | 2019-27047 | 0 | 0 | 090000648421276f | |
| FDA-2018-N-0628-0026 | FDA | None FDA-2018-N-0628 | eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff | Other | Guidance | 2019-12-16T05:00:00Z | 2019 | 12 | 2019-12-16T05:00:00Z | 2024-11-12T23:14:56Z | 1 | 0 | 09000064842407e7 | ||
| FDA-2018-N-0628-0004 | FDA | None FDA-2018-N-0628 | 03 - eCopy Proposed Rule Regulatory Impact Analysis | Supporting & Related Material | Background Material | 2018-09-13T04:00:00Z | 2018 | 9 | 2018-09-13T16:17:23Z | 0 | 0 | 09000064836e8426 | |||
| FDA-2018-N-0628-0002 | FDA | None FDA-2018-N-0628 | 01 - Reference 1-Guidance for eCopy Program for Medical Device Submissions | Supporting & Related Material | Background Material | 2018-09-13T04:00:00Z | 2018 | 9 | 2018-09-13T16:15:36Z | 0 | 0 | 09000064836e8424 | |||
| FDA-2018-N-0628-0003 | FDA | None FDA-2018-N-0628 | 02 - Reference 2-Electronic Submissions Gateway | Supporting & Related Material | Background Material | 2018-09-13T04:00:00Z | 2018 | 9 | 2018-09-13T16:16:30Z | 0 | 0 | 09000064836e8425 | |||
| FDA-2018-N-0628-0001 | FDA | None FDA-2018-N-0628 | Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Allowed in Electronic Format | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2018-09-13T04:00:00Z | 2018 | 9 | 2018-09-13T04:00:00Z | 2018-12-13T04:59:59Z | 2018-12-12T02:03:47Z | 2018-19865 | 0 | 0 | 09000064836e65a5 |
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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;