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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

8 rows where docket_id = "FDA-2015-N-3785" sorted by posted_date descending

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posted_year 4

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-N-3785-0012 FDA None FDA-2015-N-3785 Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide; Availability Notice Notice of Availability 2020-05-04T04:00:00Z 2020 5 2020-05-04T04:00:00Z   2020-05-04T17:16:54Z 2020-09188 0 0 090000648455007f
FDA-2015-N-3785-0011 FDA None FDA-2015-N-3785 Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide Guidance for Industry and Food and Drug Administration Staff Other Guidance 2020-05-01T04:00:00Z 2020 5 2020-05-01T04:00:00Z   2024-11-06T23:35:50Z   1 0 090000648452d524
FDA-2015-N-3785-0010 FDA None FDA-2015-N-3785 Reference 1 for the Final Rule (FRIA) - Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems Other Additional Information 2019-04-03T04:00:00Z 2019 4 2019-04-03T04:00:00Z   2019-04-03T14:04:20Z   0 0 0900006483b5dfbb
FDA-2015-N-3785-0009 FDA None FDA-2015-N-3785 Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems Rule Final Rule 2019-04-01T04:00:00Z 2019 4 2019-04-01T04:00:00Z   2019-04-01T16:22:28Z 2019-06024 0 0 0900006483b511b1
FDA-2015-N-3785-0008 FDA None FDA-2015-N-3785 Reference 2 - Transcript and Other Meeting Materials from the FDA Orthopedic Devices Panel Meeting, September 21, 2012 re Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems Supporting & Related Material Background Material 2018-11-14T05:00:00Z 2018 11     2018-11-14T15:25:01Z   0 0 09000064838d5fc9
FDA-2015-N-3785-0003 FDA None FDA-2015-N-3785 Reference 2 - Transcript and Other Meeting Materials from the FDA Orthopedic Devices Panel Meeting, September 21, 2012 re Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems Supporting & Related Material Background Material 2016-03-10T05:00:00Z 2016 3     2018-11-14T15:26:33Z   0 0 0900006481eb80fc
FDA-2015-N-3785-0001 FDA None FDA-2015-N-3785 Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems Proposed Rule Notice of Proposed Rulemaking (NPRM) 2016-03-10T05:00:00Z 2016 3 2016-03-10T05:00:00Z 2016-06-09T03:59:59Z 2016-06-09T01:00:36Z 2016-05384 0 0 0900006481eb8198
FDA-2015-N-3785-0002 FDA None FDA-2015-N-3785 Reference 1 - Orthopedic Surgical Manufacturers Association (OSMA) Reclassification Petition - Lateral Mass and Pedicle Screw Spinal Systems (Cervical Spine) re Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems Supporting & Related Material Background Material 2016-03-10T05:00:00Z 2016 3     2016-03-10T21:25:39Z   0 0 0900006481eb80fb

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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;