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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

12 rows where docket_id = "FDA-2014-N-1209" sorted by posted_date descending

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posted_year 3

  • 2016 9
  • 2017 2
  • 2019 1

document_type 3

  • Supporting & Related Material 10
  • Proposed Rule 1
  • Rule 1

agency_id 1

  • FDA 12
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2014-N-1209-0315 FDA None FDA-2014-N-1209 Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Devices Intended To Treat Anxiety and/ or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended To Treat Depression Rule Final Rule 2019-12-20T05:00:00Z 2019 12 2019-12-20T05:00:00Z   2019-12-20T13:47:06Z 2019-27295 0 0 0900006484240022
FDA-2014-N-1209-0313 FDA None FDA-2014-N-1209 Fisher Wallace Memo January 9 Supporting & Related Material Memorandum 2017-02-02T05:00:00Z 2017 2     2017-02-02T14:47:31Z   0 0 09000064824a545f
FDA-2014-N-1209-0314 FDA None FDA-2014-N-1209 Letter accompanying Submission to Proposed Order Docket FWL Supporting & Related Material Letter 2017-02-02T05:00:00Z 2017 2     2017-02-02T14:48:12Z   0 0 09000064824a5460
FDA-2014-N-1209-0003 FDA None FDA-2014-N-1209 Reference 33, Studies of Electrosleep on Normal Adults, Insomniacs, and Hypertensive Patients re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression Supporting & Related Material Background Material 2016-01-22T05:00:00Z 2016 1     2016-01-22T17:55:45Z   0 0 0900006481e2919e
FDA-2014-N-1209-0005 FDA None FDA-2014-N-1209 Reference 31, Does Electrosleep Induce Natural Sleep? re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression Supporting & Related Material Background Material 2016-01-22T05:00:00Z 2016 1     2016-01-22T17:56:07Z   0 0 0900006481e2919c
FDA-2014-N-1209-0001 FDA None FDA-2014-N-1209 Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression Proposed Rule Notice of Proposed Rulemaking (NPRM) 2016-01-22T05:00:00Z 2016 1 2016-01-22T05:00:00Z 2016-04-22T03:59:59Z 2016-06-15T01:00:33Z 2016-01173 0 0 0900006481e2882d
FDA-2014-N-1209-0007 FDA None FDA-2014-N-1209 Reference 30 Quantitative EEG Analysis of Electrosleep Using Analog Frequency Analyzer and Digital Computer Methods re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression Supporting & Related Material Background Material 2016-01-22T05:00:00Z 2016 1     2016-01-22T17:57:04Z   0 0 0900006481e29196
FDA-2014-N-1209-0009 FDA None FDA-2014-N-1209 Reference 2 - FDA Executive Summary, Prepared for the February 10, 2012, meeting of the Neurological Devices Panel re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression Supporting & Related Material Background Material 2016-01-22T05:00:00Z 2016 1     2016-01-22T18:05:28Z   0 0 0900006481e28c87
FDA-2014-N-1209-0006 FDA None FDA-2014-N-1209 Reference 35, A Clinical Trial of Cranial Electrotherapy Stimulation for Anxiety and Comorbid Depression re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression Supporting & Related Material Background Material 2016-01-22T05:00:00Z 2016 1     2016-01-22T17:56:55Z   0 0 0900006481e290f4
FDA-2014-N-1209-0002 FDA None FDA-2014-N-1209 List of References re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression Supporting & Related Material Background Material 2016-01-22T05:00:00Z 2016 1     2016-01-22T17:55:33Z   0 0 0900006481e28c37
FDA-2014-N-1209-0004 FDA None FDA-2014-N-1209 Reference 32, Ineffectiveness of Elctrosleep in Chronic Primary Insomnia re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression Supporting & Related Material Background Material 2016-01-22T05:00:00Z 2016 1     2016-01-22T17:55:56Z   0 0 0900006481e2919d
FDA-2014-N-1209-0008 FDA None FDA-2014-N-1209 Reference 1 - Transcript, February 10, 2012, meeting of the Neurological Devices Panel of the Medical Device Advisory Committee re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression Supporting & Related Material Background Material 2016-01-22T05:00:00Z 2016 1     2016-01-22T18:03:24Z   0 0 0900006481e28c86

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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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