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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-2008-N-0393" sorted by posted_date descending

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

posted_year 4

  • 2014 4
  • 2009 2
  • 2010 1
  • 2015 1

document_type 4

  • Other 3
  • Proposed Rule 2
  • Rule 2
  • Notice 1

agency_id 1

  • FDA 8
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2008-N-0393-0015 FDA None FDA-2008-N-0393 Medical Device Reporting: Electronic Submission Requirements; Correcting Amendments Rule Final Rule 2015-02-27T05:00:00Z 2015 2 2015-02-27T05:00:00Z   2015-02-27T15:41:40Z 2015-03943 0 0 0900006481a1d39d
FDA-2008-N-0393-0014 FDA None FDA-2008-N-0393 OMB Review, Executive Order 12866, Medical Device Reporting: Electronic Submission Requirements February 14, 2014– Memorandum Other References (internal) (REF) 2014-03-12T04:00:00Z 2014 3 2014-03-12T04:00:00Z   2014-03-12T17:26:02Z   0 0 0900006481661a66
FDA-2008-N-0393-0013 FDA None FDA-2008-N-0393 Medical Device Reporting: Electronic Submission Requirements Rule Final Rule 2014-02-14T05:00:00Z 2014 2 2014-02-14T05:00:00Z   2014-02-14T17:29:16Z 2014-03279 0 0 09000064815663fd
FDA-2008-N-0393-0011 FDA None FDA-2008-N-0393 Questions and Answers About Electronic Medical Device Reporting; Availability Notice Notice of Availability 2014-02-14T05:00:00Z 2014 2 2014-02-14T05:00:00Z   2014-02-14T17:07:54Z 2014-03276 0 0 09000064815661b9
FDA-2008-N-0393-0012 FDA None FDA-2008-N-0393 Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff Other Guidance 2014-02-13T05:00:00Z 2014 2 2014-02-13T05:00:00Z   2024-11-11T20:48:51Z   1 0 090000648156798c
FDA-2008-N-0393-0010 FDA None FDA-2008-N-0393 OMB Review, Executive Order 12866, Regulatory Policy and Management Staff Note to the Division of Dockets Management, March 19, 2010" - [Medical Device Reporting: Electronic Submission Requirements; Proposed Rule, August 21, 2009] - Reference Other REF-Reference 2010-03-29T04:00:00Z 2010 3 2010-03-29T04:00:00Z   2013-08-11T01:33:22Z   0 0 0900006480ac76f6
FDA-2008-N-0393-0002 FDA None FDA-2008-N-0393 Medical Device Reporting: Electronic Submission Requirements Proposed Rule NCR-Notice of Correction 2009-08-25T04:00:00Z 2009 8 2009-08-25T04:00:00Z 2009-11-20T04:59:59Z 2011-06-11T16:27:46Z Z9-19683 0 0 0900006480a11bb1
FDA-2008-N-0393-0001 FDA None FDA-2008-N-0393 Medical Device Reporting: Electronic Submission Requirements Proposed Rule NPR-Notice of Proposed Rule-Making 2009-08-21T04:00:00Z 2009 8 2009-08-21T04:00:00Z 2009-11-20T04:59:59Z 2011-06-11T16:27:46Z E9-19683 0 0 0900006480a0f543

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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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