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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

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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, open_for_comment, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 4

  • 2019 7
  • 2018 4
  • 2021 1
  • 2025 1

document_type 4

  • Supporting & Related Material 7
  • Other 4
  • Proposed Rule 1
  • Rule 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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;
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