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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

6 rows where docket_id = "FDA-2011-N-0661" and posted_year = 2016 sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 5
  • Rule 1

posted_year 1

  • 2016 · 6 ✖

agency_id 1

  • FDA 6
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0661-0009 FDA None FDA-2011-N-0661 Reference 2 - The Orthopaedic forumRisk Stratification Algorithm for Management of Patients with Metal-on-Metal Hip Arthroplasty Consensus Statement of the American Association of Hip and Knee Surgeons, the American Academy of Orthopaedic Surgeons, and The Hip Society re Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems Supporting & Related Material Background Material 2016-02-18T05:00:00Z 2016 2     2016-02-25T14:55:42Z   0 0 0900006481e76b91
FDA-2011-N-0661-0011 FDA None FDA-2011-N-0661 Reference 4 - FDA Executive Summary Memorandum Metal-on-Metal Hip Implant Systems June 27, 2012 re Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems Supporting & Related Material Background Material 2016-02-18T05:00:00Z 2016 2     2016-02-25T14:56:15Z   0 0 0900006481e76bb7
FDA-2011-N-0661-0008 FDA None FDA-2011-N-0661 Reference 1 - ORTHOPAEDICS AND REHABILITATION DEVICES ADVISORY PANEL Wednesday, August 8, 2001 re Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems Supporting & Related Material Background Material 2016-02-18T05:00:00Z 2016 2     2016-02-25T14:55:15Z   0 0 0900006481e76b90
FDA-2011-N-0661-0010 FDA None FDA-2011-N-0661 Reference 3 - Metal-on-Metal Hip Implants Information for Orthopaedic Surgeons re Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems Supporting & Related Material Background Material 2016-02-18T05:00:00Z 2016 2     2016-02-25T14:56:06Z   0 0 0900006481e76b92
FDA-2011-N-0661-0007 FDA None FDA-2011-N-0661 Effective Date of Requirement for Premarket Approval for Total Metal-on- Metal Semi-Constrained Hip Joint Systems Rule Final Rule 2016-02-18T05:00:00Z 2016 2 2016-02-18T05:00:00Z   2016-02-18T15:39:05Z 2016-03331 0 0 0900006481e74b06
FDA-2011-N-0661-0012 FDA None FDA-2011-N-0661 Reference 5 - ORTHOPAEDIC AND REHABILITATION DEVICES Panel Transcript June 28 2012 re Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems Supporting & Related Material Background Material 2016-02-18T05:00:00Z 2016 2     2016-02-25T14:56:26Z   0 0 0900006481e76bb8

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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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