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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

37 rows where docket_id = "FDA-2009-M-0101" sorted by posted_date descending

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posted_year 8

  • 2011 8
  • 2012 7
  • 2013 7
  • 2009 6
  • 2010 5
  • 2014 2
  • 2015 1
  • 2017 1

document_type 3

  • Other 20
  • Supporting & Related Material 16
  • Notice 1

agency_id 1

  • FDA 37
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-M-0101-0124 FDA None FDA-2009-M-0101 Letter from CDRH to Orthopedic Surgical Manufacturers Association (OSMA) Other Letter(s) 2017-06-26T04:00:00Z 2017 6 2017-06-26T04:00:00Z   2017-06-26T16:48:39Z   0 0 0900006482796fd3
FDA-2009-M-0101-0123 FDA None FDA-2009-M-0101 Petition Denial letter to Philips Healthcare Other Denial of Petition 2015-01-29T05:00:00Z 2015 1 2015-01-29T05:00:00Z   2015-01-29T12:39:08Z   0 0 09000064819e52e0
FDA-2009-M-0101-0122 FDA None FDA-2009-M-0101 FDA/CDRH Response Letter to Osypka Medical, Inc., September 16, 2014 re Reclassification Petition FDA-2009-M-0101-0172 Other Letter(s) 2014-09-19T04:00:00Z 2014 9 2014-09-19T04:00:00Z   2014-09-19T13:17:04Z   0 0 090000648187ee54
FDA-2009-M-0101-0121 FDA None FDA-2009-M-0101 FDA/CDRH Response Letter to Osypka Medical, Inc., September 16, 2014 re Reclassification Petition FDA-2009-M-0101-0171 Other Letter(s) 2014-09-19T04:00:00Z 2014 9 2014-09-19T04:00:00Z   2014-09-19T13:12:32Z   0 0 090000648187ee53
FDA-2009-M-0101-0120 FDA None FDA-2009-M-0101 Pediatric Orthopaedic Society of North America (POSNA) and Scoliosis Research Sciety (SRS) - Comment re FDA-2009-M-0101-DRAFT-0034 Other Change in Classification Petition 2013-05-24T04:00:00Z 2013 5 2013-05-24T04:00:00Z   2013-05-24T20:23:25Z   0 0 0900006480b39d1f
FDA-2009-M-0101-0113 FDA None FDA-2009-M-0101 FDA/CDRH Response Letter to Philips Healthcare December 27, 2012 - Letter Other Letter(s) 2013-03-08T05:00:00Z 2013 3 2013-03-08T05:00:00Z   2024-11-07T22:52:52Z   1 0 090000648121feaa
FDA-2009-M-0101-0111 FDA None FDA-2009-M-0101 Leonhard Lang - Petition for Reclassification re FDA-2009-M-0101-0037 Other Change in Classification Petition 2013-02-25T05:00:00Z 2013 2 2013-02-25T05:00:00Z   2013-07-27T22:51:36Z   0 0 0900006480a05bde
FDA-2009-M-0101-0091 FDA None FDA-2009-M-0101 Jolife, AB (Hogan & Hartson, LLP) - Petition for Reclassification Other Change in Classification Petition 2013-01-29T05:00:00Z 2013 1 2013-01-29T05:00:00Z   2013-07-27T22:52:24Z   0 0 0900006480a0dd5a
FDA-2009-M-0101-0095 FDA None FDA-2009-M-0101 Biomet Manufacturing Corp. - Petition for Reclassification Other Change in Classification Petition 2013-01-29T05:00:00Z 2013 1 2013-01-29T05:00:00Z   2013-07-27T22:53:14Z   0 0 0900006480a18bd1
FDA-2009-M-0101-0092 FDA None FDA-2009-M-0101 Michigan Instruments - Petition for Reclassification Other Change in Classification Petition 2013-01-29T05:00:00Z 2013 1 2013-01-29T05:00:00Z   2013-07-27T22:52:24Z   0 0 0900006480a0dd58
FDA-2009-M-0101-0096 FDA None FDA-2009-M-0101 Biomet Manufacturing Corporation - Petition for Reclassification Amendment re FDA-2009-M-0101-0095 Other Amendment 2013-01-29T05:00:00Z 2013 1 2013-01-29T05:00:00Z   2013-01-30T02:40:34Z   0 0 0900006480a2c7f0
FDA-2009-M-0101-0056 FDA None FDA-2009-M-0101 Philips Healthcare to FDA/CDRH - Letter re FDA-2009-M-0101-0044 Other Letter(s) 2012-07-10T04:00:00Z 2012 7     2012-07-10T15:46:32Z   0 0 0900006481083a0a
FDA-2009-M-0101-0051 FDA None FDA-2009-M-0101 Attachment 1- re Diapulse Corporation of America - Information Supporting & Related Material Information Collection Documentation 2012-07-08T04:00:00Z 2012 7     2012-07-08T14:47:25Z   0 0 090000648107e66c
FDA-2009-M-0101-0047 FDA None FDA-2009-M-0101 Letter to Philips Healthcare Other Letter(s) 2012-06-15T04:00:00Z 2012 6 2012-06-15T04:00:00Z   2024-11-12T05:04:08Z   1 0 090000648103c2f7
FDA-2009-M-0101-0048 FDA None FDA-2009-M-0101 American Academy of Orthopaedic Surgeons (AAOS) et al - (re Orthopedic Surgical Manufacturers Association (OSMA) - Petition for Reclassification) - Comment Other Change in Classification Petition 2012-06-15T04:00:00Z 2012 6 2012-06-15T04:00:00Z   2012-06-15T20:05:45Z   0 0 0900006480b73226
FDA-2009-M-0101-0046 FDA None FDA-2009-M-0101 Spire Biomedical Incorporated - Petition for Reclassification re FDA-2009-M-0101-0027 Other Change in Classification Petition 2012-06-15T04:00:00Z 2012 6 2012-06-15T04:00:00Z   2013-07-27T22:54:41Z   0 0 0900006480a241f2
FDA-2009-M-0101-0044 FDA None FDA-2009-M-0101 Philips Medical Systems Cardiac Care - Petition for Reclassification Other Change in Classification Petition 2012-04-09T04:00:00Z 2012 4 2012-04-09T04:00:00Z   2012-04-09T22:40:24Z   0 0 0900006480a05f81
FDA-2009-M-0101-0043 FDA None FDA-2009-M-0101 Philips Healthcare to FDA/CDRH - Letter Other Letter(s) 2012-04-09T04:00:00Z 2012 4 2010-01-11T05:00:00Z   2024-11-12T05:01:36Z   1 0 0900006480fec285
FDA-2009-M-0101-0040 FDA None FDA-2009-M-0101 Philips Medical Systems Cardiac Care - Petition for Reclassification Other Change in Classification Petition 2011-12-12T05:00:00Z 2011 12 2011-12-12T05:00:00Z   2013-07-28T00:10:31Z   0 0 0900006480f80aac
FDA-2009-M-0101-0029 FDA None FDA-2009-M-0101 Merit Medical Systems, Inc. - Information re FDA-2009-M-0101-DRAFT-0122 and 0043 Supporting & Related Material Reference (external attachments) 2011-12-12T05:00:00Z 2011 12     2011-12-12T19:22:58Z   0 0 0900006480f80465
FDA-2009-M-0101-0033 FDA None FDA-2009-M-0101 Appendix B - Cited Articles re Smiths Medical ASD, Inc. - Information FDA-2009-M-0101-DRAFT-0033 Supporting & Related Material Reference (external attachments) 2011-12-12T05:00:00Z 2011 12     2011-12-12T21:54:31Z   0 0 0900006480f809f8
FDA-2009-M-0101-0037 FDA None FDA-2009-M-0101 Leonhard Lang - Petition for Reclassification re FDA-2009-M-0101-0111 Other Change in Classification Petition 2011-12-12T05:00:00Z 2011 12 2011-12-12T05:00:00Z   2013-08-11T01:44:59Z   0 0 0900006480f80a51
FDA-2009-M-0101-0028 FDA None FDA-2009-M-0101 American Academy of Orthopaedic Surgeons (AAOS) - [(re Orthopedic Surgical Manufacturers Association (OSMA) - Petition for Reclassification) - Comment] - Background Material Supporting & Related Material Change in Classification Petition 2011-07-25T04:00:00Z 2011 7     2011-07-25T23:12:40Z   0 0 0900006480eca49e
FDA-2009-M-0101-0027 FDA None FDA-2009-M-0101 Appendix IV - Copies of Reference Literature (Spire Biomedical Incorporated - Petition for Reclassification) re FDA-2009-M-0101-0046 Supporting & Related Material Change in Classification Petition 2011-07-25T04:00:00Z 2011 7     2012-06-15T19:50:19Z   0 0 0900006480b4686a
FDA-2009-M-0101-0023 FDA None FDA-2009-M-0101 Bard Access Systems, Inc. - Information Supporting & Related Material Information Collection Documentation 2011-07-25T04:00:00Z 2011 7     2011-12-12T19:04:57Z   0 0 0900006480b4683e
FDA-2009-M-0101-0026 FDA None FDA-2009-M-0101 Zimmer, Inc. - Information re FDA-2009-M-0101-0094 Supporting & Related Material Information Collection Documentation 2011-07-25T04:00:00Z 2011 7     2013-05-24T21:10:15Z   0 0 0900006480a18ae7
FDA-2009-M-0101-0010 FDA None FDA-2009-M-0101 MECTA Corporation - Petition for Reclassification Other Change in Classification Petition 2010-01-11T05:00:00Z 2010 1 2010-01-11T05:00:00Z   2013-07-27T23:04:05Z   0 0 0900006480a7b55e
FDA-2009-M-0101-0011 FDA None FDA-2009-M-0101 Appendix C "SpECTrum Safety Information" - [MECTA Corporation - Petition for Reclassification] re FDA-2009-M-0101-0010 Supporting & Related Material CCP-Change in Classification Petition 2010-01-11T05:00:00Z 2010 1     2010-03-04T16:39:21Z   0 0 0900006480a7b619
FDA-2009-M-0101-0008 FDA None FDA-2009-M-0101 Reference 8 - "Federal Register, March 24, 2003 (Volume 68, Number 56)" - [Richard Abrams, M.D. and Conrad M. Swartz, Ph.D., M.D. (Somatics, LLC) - Information] re FDA-2009-M-0101-0007 Supporting & Related Material INFO-Information (Supporting and Related Material) 2010-01-11T05:00:00Z 2010 1     2010-01-11T18:33:04Z   0 0 0900006480a0211c
FDA-2009-M-0101-0009 FDA None FDA-2009-M-0101 Reference 16 Hoyert, Division of Vital Statistics, Maternal Mortality and Related Concepts re FDA-2009-M-0101-0007 Supporting & Related Material INFO-Information (Supporting and Related Material) 2010-01-11T05:00:00Z 2010 1     2013-05-08T21:12:11Z   0 0 0900006480a02127
FDA-2009-M-0101-0012 FDA None FDA-2009-M-0101 Appendix E - "...Over Thirty-Five Years of Neuromodulation Innovations" - [MECTA Corporation - Petition for Reclassification] re FDA-2009-M-0101-0010 Supporting & Related Material CCP- Change in Certification Petition (Supporting and Related Material) 2010-01-11T05:00:00Z 2010 1     2010-03-04T16:40:30Z   0 0 0900006480a7b678
FDA-2009-M-0101-0005 FDA None FDA-2009-M-0101 Updated Submission Forthcoming - [Gish Biomedical, Inc. - Information] Supporting & Related Material   2009-07-18T00:00:00Z 2009 7     2009-07-31T20:39:43Z   0 1 09000064809f4cd2
FDA-2009-M-0101-0006 FDA None FDA-2009-M-0101 Bio Electronics Corporation - Information Supporting & Related Material   2009-07-18T00:00:00Z 2009 7     2009-07-30T18:00:17Z   0 1 09000064809f4cd3
FDA-2009-M-0101-0003 FDA None FDA-2009-M-0101 The Female Health Company - Information Supporting & Related Material   2009-06-10T00:00:00Z 2009 6     2009-06-18T17:26:15Z   0 1 09000064809a507b
FDA-2009-M-0101-0004 FDA None FDA-2009-M-0101 TMJ Implants, Inc. - Information Supporting & Related Material   2009-06-10T00:00:00Z 2009 6     2009-06-18T17:27:42Z   0 1 09000064809c6c0c
FDA-2009-M-0101-0002 FDA None FDA-2009-M-0101 GE Healthcare - Information Supporting & Related Material   2009-06-10T00:00:00Z 2009 6     2009-06-18T17:25:00Z   0 1 0900006480991dbb
FDA-2009-M-0101-0001 FDA None FDA-2009-M-0101 Medical Devices; Order for Certain Class III Devices; Submission of Safety and Effectiveness Information Notice N-Notice 2009-04-09T04:00:00Z 2009 4 2009-04-09T04:00:00Z 2009-08-08T03:59:59Z 2013-05-10T01:05:57Z E9-08022 0 0 090000648094bbd0

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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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