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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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12 rows where docket_id = "FDA-2017-N-1129" sorted by posted_date descending

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agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2017-N-1129-0058 FDA None FDA-2017-N-1129 Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff Other Guidance 2020-05-04T04:00:00Z 2020 5 2020-05-04T04:00:00Z   2024-11-06T23:35:53Z   1 0 090000648452df2a
FDA-2017-N-1129-0057 FDA None FDA-2017-N-1129 Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices Rule Final Rule 2019-12-30T05:00:00Z 2019 12 2019-12-30T05:00:00Z   2019-12-30T16:00:40Z 2019-27394 0 0 090000648425877b
FDA-2017-N-1129-0056 FDA None FDA-2017-N-1129 Medical Devices; Exemptions From Premarket Notification: Class II Devices Rule Final Rule 2018-06-05T04:00:00Z 2018 6 2018-06-05T04:00:00Z   2018-06-05T13:31:25Z 2018-11879 0 0 090000648333c407
FDA-2017-N-1129-0054 FDA None FDA-2017-N-1129 Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments Notice Request for Comments 2017-11-07T05:00:00Z 2017 11 2017-11-07T05:00:00Z 2018-01-09T04:59:59Z 2018-01-09T02:02:27Z 2017-24163 0 0 0900006482c53f22
FDA-2017-N-1129-0053 FDA None FDA-2017-N-1129 Medical Devices: Exemptions from Premarket Notification; Class II Devices Notice Announcement 2017-07-11T04:00:00Z 2017 7 2017-07-11T04:00:00Z   2017-07-11T13:55:40Z 2017-14453 0 0 0900006482908cce
FDA-2017-N-1129-0048 FDA None FDA-2017-N-1129 Attachment 2 Beger et al Metabolomics enables precision medicine: "A White Paper, Community Perspective" Metabolomics (20 16) I 2:149 re: Comment from Bruker Supporting & Related Material Background Material 2017-05-16T04:00:00Z 2017 5     2017-05-16T18:35:46Z   0 0 09000064825c9a37
FDA-2017-N-1129-0051 FDA None FDA-2017-N-1129 Attachment 9 Becker, E. High Resolution NMR (Third Edition) Theory and Chemical Applications Table of Contents re: Comment from Bruker Supporting & Related Material Background Material 2017-05-16T04:00:00Z 2017 5     2017-05-16T19:16:07Z   0 0 09000064825c9a3d
FDA-2017-N-1129-0047 FDA None FDA-2017-N-1129 Attachment 1 Improvement of Biological Product Quality by Application of New Technologies to Characterize of Vaccines and Blood Products: NMR Spectroscopy and Light Scattering re: Comment from Bruker Supporting & Related Material Background Material 2017-05-16T04:00:00Z 2017 5     2017-05-16T18:29:25Z   0 0 09000064825c9a36
FDA-2017-N-1129-0049 FDA None FDA-2017-N-1129 Attachment 7 History of Bruker re: Comment from Bruker Supporting & Related Material Background Material 2017-05-16T04:00:00Z 2017 5     2017-05-16T19:08:41Z   0 0 09000064825c9a3b
FDA-2017-N-1129-0050 FDA None FDA-2017-N-1129 Attachment 8 Becker, E. A Brief History of Nuclear Magnetic Resonance Anal Chemistry, 65, 6, (1993) re: Comment from Bruker Supporting & Related Material Background Material 2017-05-16T04:00:00Z 2017 5     2017-05-16T19:12:10Z   0 0 09000064825c9a3c
FDA-2017-N-1129-0001 FDA None FDA-2017-N-1129 Medical Devices: Exemptions From Premarket Notification; Class II Devices; Request for Comments Notice Request for Comments 2017-03-14T04:00:00Z 2017 3 2017-03-14T04:00:00Z 2017-05-16T03:59:59Z 2017-05-19T01:00:33Z 2017-04938 0 0 0900006482505fe7
FDA-2017-N-1129-0002 FDA None FDA-2017-N-1129 Reference 1 - Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff re: Medical Devices: Exemptions From Premarket Notification; Class II Devices; Request for Comments Supporting & Related Material Background Material 2017-03-14T04:00:00Z 2017 3     2024-11-07T00:55:24Z   0 0 090000648250645f

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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;