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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

15 rows where docket_id = "FDA-2011-N-0504" sorted by posted_date descending

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

posted_year 3

  • 2011 11
  • 2014 3
  • 2019 1

document_type 2

  • Other 13
  • Proposed Rule 2

agency_id 1

  • FDA 15
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-N-0504-0195 FDA None FDA-2011-N-0504 Petition Response Letter from FDA CDRH to Electromedical Products International, Inc. Other Agency Response 2019-12-20T05:00:00Z 2019 12 2019-12-20T05:00:00Z   2019-12-20T17:20:09Z   0 0 09000064842423de
FDA-2011-N-0504-0192 FDA None FDA-2011-N-0504 Withdrawal from Neuro Fitness, LLC Other Withdrawal 2014-07-15T04:00:00Z 2014 7 2014-07-15T04:00:00Z   2014-07-15T17:01:27Z   0 0 0900006481751513
FDA-2011-N-0504-0191 FDA None FDA-2011-N-0504 Withdrawal from Fisher Wallace Laboratories Other Withdrawal 2014-07-14T04:00:00Z 2014 7 2014-07-14T04:00:00Z   2014-08-13T16:30:28Z   0 0 0900006481759fcc
FDA-2011-N-0504-0190 FDA None FDA-2011-N-0504 Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Proposed Rule Withdrawal 2014-06-12T04:00:00Z 2014 6 2014-06-12T04:00:00Z   2014-06-12T15:03:32Z 2014-13756 0 0 0900006481740b58
FDA-2011-N-0504-0031 FDA None FDA-2011-N-0504 Fisher Wallace Laboratories, LLC - Reclassification Petition Other Change in Classification Petition 2011-09-01T04:00:00Z 2011 9 2011-09-01T04:00:00Z   2014-08-27T22:54:45Z   0 0 0900006480eea73f
FDA-2011-N-0504-0028 FDA None FDA-2011-N-0504 FDA/OC Executive Secretariat Response to C. Norman Shealy, M.D., Ph.D., August 26, 2011 - Letter Other Letter(s) 2011-09-01T04:00:00Z 2011 9 2011-09-01T04:00:00Z   2011-09-01T20:19:01Z   0 0 0900006480f0d0cc
FDA-2011-N-0504-0032 FDA None FDA-2011-N-0504 Acknowledgement Letter to Fisher Wallace Laboratories, LLC Other Acknowledgement Letter/Receipt 2011-09-01T04:00:00Z 2011 9 2011-09-01T04:00:00Z   2011-09-01T19:54:34Z   0 0 0900006480eeb4af
FDA-2011-N-0504-0030 FDA None FDA-2011-N-0504 Acknowledgement Letter to Electromedical Products International, Inc. Other Acknowledgement Letter/Receipt 2011-09-01T04:00:00Z 2011 9 2011-09-01T04:00:00Z   2011-09-01T19:14:40Z   0 0 0900006480ef8fa2
FDA-2011-N-0504-0034 FDA None FDA-2011-N-0504 Acknowledgement Letter to Neuro Fitness LLC Other Acknowledgement Letter/Receipt 2011-09-01T04:00:00Z 2011 9 2011-09-01T04:00:00Z   2011-09-01T20:14:40Z   0 0 0900006480ef5cf0
FDA-2011-N-0504-0029 FDA None FDA-2011-N-0504 Electromedical Products International, Inc. (EPI) - Reclassification Petition Other Change in Classification Petition 2011-09-01T04:00:00Z 2011 9 2011-09-01T04:00:00Z   2024-11-07T22:36:41Z   1 0 0900006480ee95c6
FDA-2011-N-0504-0033 FDA None FDA-2011-N-0504 Neuro Fitness LLC - Reclassification Petition Other Change in Classification Petition 2011-09-01T04:00:00Z 2011 9 2011-09-01T04:00:00Z   2024-11-07T22:35:29Z   1 0 0900006480ef5cee
FDA-2011-N-0504-0016 FDA None FDA-2011-N-0504 Fisher Wallace Laboratories, LLC - Request for Extention Other Request for Extension 2011-08-25T04:00:00Z 2011 8 2011-08-25T04:00:00Z   2013-08-11T03:16:48Z   0 0 0900006480eea2e2
FDA-2011-N-0504-0003 FDA None FDA-2011-N-0504 Fisher Wallace Laboratories - Request for Extension Other Citizen Petition 2011-08-24T04:00:00Z 2011 8 2011-08-24T04:00:00Z   2013-08-11T03:16:41Z   0 0 0900006480ee5806
FDA-2011-N-0504-0002 FDA None FDA-2011-N-0504 Fisher Wallace Laboratories, LLC - Request for Extension Other Request for Extension 2011-08-23T04:00:00Z 2011 8 2011-08-23T04:00:00Z   2011-08-23T16:06:58Z   0 0 0900006480ee1f63
FDA-2011-N-0504-0001 FDA None FDA-2011-N-0504 Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-08-08T04:00:00Z 2011 8 2011-08-08T04:00:00Z 2011-11-08T04:59:59Z 2011-08-24T16:36:04Z 2011-19957 0 0 0900006480ed9ea7

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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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