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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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44 rows where docket_id = "FDA-2016-N-0400" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-N-0400-0191 FDA None FDA-2016-N-0400 Medical Devices; General and Plastic Surgery Devices; Reclassification of Blood Lancets Rule Final Rule 2021-11-22T05:00:00Z 2021 11 2021-11-22T05:00:00Z   2021-11-22T15:51:30Z 2021-25376 0 0 0900006484e71279
FDA-2016-N-0400-0182 FDA None FDA-2016-N-0400 Request for Extension from Anonymous Other Request for Extension 2016-06-01T04:00:00Z 2016 6 2016-06-01T04:00:00Z   2016-06-01T21:03:08Z   0 0 0900006482006a50
FDA-2016-N-0400-0003 FDA None FDA-2016-N-0400 Reference 1 - Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:50:54Z   0 0 0900006481e9edc4
FDA-2016-N-0400-0006 FDA None FDA-2016-N-0400 Reference 4 - Epidemiologic Notes and Reports Nosocomial Transmission of Hepatitis B Virus Associated with a Spring-Loaded Fingerstick Device-California re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:52:21Z   0 0 0900006481e9edc7
FDA-2016-N-0400-0041 FDA None FDA-2016-N-0400 Reference 39 - Point-of-Care Blood Glucose Testing for Diabetes Care in Hospitalized Patients An Evidence-Based Review re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:11:50Z   0 0 0900006481e9f116
FDA-2016-N-0400-0025 FDA None FDA-2016-N-0400 Reference 23 - . Infection Control Practices in Assisted Living Facilities A Response to Hepatitis B Virus Infection Outbreaks re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:04:36Z   0 0 0900006481e9eccb
FDA-2016-N-0400-0016 FDA None FDA-2016-N-0400 Reference 14 - Transmission of Hepatitis B Infection During Home Blood Glucose Monitoring re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:56:30Z   0 0 0900006481e9ee78
FDA-2016-N-0400-0039 FDA None FDA-2016-N-0400 Reference 37 - Glucose Biosensors An Overview of Use in Clinical Practice re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:11:15Z   0 0 0900006481e9f114
FDA-2016-N-0400-0029 FDA None FDA-2016-N-0400 Reference 27 - “Never Events” Hepatitis B Outbreaks and patient Notifications Resulting from Unsafe Practices during Assisted Monitoring of Blood Glucose, 2009-2010 re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:06:10Z   0 0 0900006481e9ece5
FDA-2016-N-0400-0004 FDA None FDA-2016-N-0400 Reference 2 Blood Lancet Labeling - re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:51:28Z   0 0 0900006481e9edc5
FDA-2016-N-0400-0035 FDA None FDA-2016-N-0400 Reference 33 - Viral Hepatitis Transmission in Ambulatory Health Care Settings re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:08:38Z   0 0 0900006481e9eceb
FDA-2016-N-0400-0005 FDA None FDA-2016-N-0400 Reference 3 - FDA’s General and Plastic Surgery Devices Panel transcript and other meeting materials for the June 26, 2013 meeting re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:51:53Z   0 0 0900006481e9edc6
FDA-2016-N-0400-0022 FDA None FDA-2016-N-0400 Reference 20 - Transmission of Hepatitis B Virus Among Persons Undergoing Blood Glucose Monitoring in Long-Term-Care Facilities – Mississippi, North Carolina, and Los Angeles County, California, 2003-2004 re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:03:43Z   0 0 0900006481e9ecc8
FDA-2016-N-0400-0023 FDA None FDA-2016-N-0400 Reference 21 - Eliminating the Blood Outbreaks of Hepatitis B Virus Infection and the Need for Innovative Glucose Monitoring Technologies re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:03:57Z   0 0 0900006481e9ecc9
FDA-2016-N-0400-0042 FDA None FDA-2016-N-0400 Reference 40 - Survey and Certification Memorandum re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:12:11Z   0 0 0900006481e9f117
FDA-2016-N-0400-0021 FDA None FDA-2016-N-0400 Reference 19 - Nosocomial Transmission of Hepatitis B Virus Infection Among Residents with Diabetes in a Skilled Nursing Facility re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:02:03Z   0 0 0900006481e9ecc7
FDA-2016-N-0400-0024 FDA None FDA-2016-N-0400 Reference 22 - Evaluation of the Potential for Bloodborne Pathogen Transmission Associated with Diabetes Care Practices in Nursing Homes and Assisted Living Facilities, Pinellas County re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:04:13Z   0 0 0900006481e9ecca
FDA-2016-N-0400-0027 FDA None FDA-2016-N-0400 Reference 25 - Notes from the Field: Deaths from Acute Hepatitis B Virus Infection Associated with Assisted Blood Glucose Monitoring in an Assisted –Living Facility-North Carolina, August--October 2010 re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:05:29Z   0 0 0900006481e9eccd
FDA-2016-N-0400-0008 FDA None FDA-2016-N-0400 Reference 6 - Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:53:12Z   0 0 0900006481e9ee70
FDA-2016-N-0400-0011 FDA None FDA-2016-N-0400 Reference 9 - Contamination of a Fingerstick Device re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:54:41Z   0 0 0900006481e9ee73
FDA-2016-N-0400-0009 FDA None FDA-2016-N-0400 Reference 7 - Nosocomial Transmission of Hepatitis B Virus Associated with the Use of a Spring-Loaded Fingerstick Device re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:53:48Z   0 0 0900006481e9ee71
FDA-2016-N-0400-0015 FDA None FDA-2016-N-0400 Reference 13 - Transmission of Hepatitis B During Blood Glucose Monitoring re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:56:08Z   0 0 0900006481e9ee77
FDA-2016-N-0400-0017 FDA None FDA-2016-N-0400 Reference 15 -Fulminant Hepatic Failure Due to Acute Hepatitis B and Delta Co-Infection Probable Bloodborne Pathogen Transmission Associated with a Spring-loaded Fingerstick Device re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:56:51Z   0 0 0900006481e9ee79
FDA-2016-N-0400-0030 FDA None FDA-2016-N-0400 Reference 28 - Transmission of HBV Among Assisted-Living-Facility Residents – Virginia, 2012 re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:06:45Z   0 0 0900006481e9ece6
FDA-2016-N-0400-0031 FDA None FDA-2016-N-0400 Reference 29 - Hepatitis C in a Ward for Cystic Fibrosis and Diabetic Patients Possible Transmission by Spring-Loaded Finger-Stick Devices for Self-Monitoring of Capillary Blood Glucose re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:07:15Z   0 0 0900006481e9ece7
FDA-2016-N-0400-0020 FDA None FDA-2016-N-0400 Reference 18 - Nonhospital Health Care-Associated Hepatitis B and C Virus Transmission: United States, 1998-2008 re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:59:04Z   0 0 0900006481e9ecc6
FDA-2016-N-0400-0028 FDA None FDA-2016-N-0400 Reference 26 - Infection Control Assessment of Ambulatory Surgical Centers re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:05:50Z   0 0 0900006481e9ece4
FDA-2016-N-0400-0037 FDA None FDA-2016-N-0400 Reference 34 - Increasing Prevalence of Diagnosed Diabetes — United States and Puerto Rico, 1995–2010 re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:10:44Z   0 0 0900006481e9eced
FDA-2016-N-0400-0007 FDA None FDA-2016-N-0400 Reference 5 - Safety Alert Medical Devices; Hepatitis B Transmission via Spring-Loaded Lancet Devices re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:52:46Z   0 0 0900006481e9edc8
FDA-2016-N-0400-0013 FDA None FDA-2016-N-0400 Reference 11 - Diabetes Mellitus A Survey of Changes in Treatment During the Last Fifteen Years re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:55:29Z   0 0 0900006481e9ee75
FDA-2016-N-0400-0040 FDA None FDA-2016-N-0400 39 Reference 38 - Point-of-Care Blood Glucose Testing for Diabetes Care in Hospitalized Patients An Evidence-Based Review re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:11:29Z   0 0 0900006481e9f115
FDA-2016-N-0400-0026 FDA None FDA-2016-N-0400 Reference 24 - Multiple Outbreaks of Hepatitis B Virus Infection Related to Assisted Monitoring of Blood Glucose Among Residents of Assisted Living Facilities – Virginia, 2009-2011 re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:05:05Z   0 0 0900006481e9eccc
FDA-2016-N-0400-0032 FDA None FDA-2016-N-0400 Reference 30 - An Outbreak of Nosocomial Hepatitis B Virus Infection in a Nursing Home for the Elderly in Antwerp (Belgium) re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:07:36Z   0 0 0900006481e9ece8
FDA-2016-N-0400-0033 FDA None FDA-2016-N-0400 Reference 31 - A Cluster of Hepatitis B Infections Associated with Incorrect Use of a Capillary Blood Sampling Device in a Nursing Home in the Netherlands, 2007 re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:07:53Z   0 0 0900006481e9ece9
FDA-2016-N-0400-0036 FDA None FDA-2016-N-0400 Reference 35 -Incidence of Diagnosed Diabetes per 1,000 Population Aged 18-79 Years, by Age, United States, 1980-2014 re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:10:30Z   0 0 0900006481e9ecec
FDA-2016-N-0400-0010 FDA None FDA-2016-N-0400 Reference 8 - An Outbreak of Hepatitis B in an Endocrinology Unit Traced to a Capillary Blood Sampling Device re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:54:13Z   0 0 0900006481e9ee72
FDA-2016-N-0400-0012 FDA None FDA-2016-N-0400 Reference 10 - History of Viral Hepatitis -A Tale of Dogmas and Misinterpretations re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:55:04Z   0 0 0900006481e9ee74
FDA-2016-N-0400-0038 FDA None FDA-2016-N-0400 Reference 36 - A History of Blood Glucose Meters and Their Role in Self-Monitoring of Diabetes Mellitus re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:10:57Z   0 0 0900006481e9f113
FDA-2016-N-0400-0002 FDA None FDA-2016-N-0400 List of References re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:50:26Z   0 0 0900006481e9edc3
FDA-2016-N-0400-0034 FDA None FDA-2016-N-0400 Reference 32 - Five Hepatitis B Outbreaks in Care Homes in the UK Associated with Deficiencies in Infection Control Practice in Blood Glucose Monitoring re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T17:08:06Z   0 0 0900006481e9ecea
FDA-2016-N-0400-0018 FDA None FDA-2016-N-0400 Reference 16- Nosocomial Hepatitis B Virus Infection Associated with Reusable Fingerstick Blood Sampling Devices – Ohio and New York City, 1996 re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:57:18Z   0 0 0900006481e9ecc4
FDA-2016-N-0400-0019 FDA None FDA-2016-N-0400 Reference 17 - Deja Vu: Nosocomial Hepatitis B Transmission and Fingerstick Monitoring re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:58:18Z   0 0 0900006481e9ecc5
FDA-2016-N-0400-0014 FDA None FDA-2016-N-0400 Reference 12 - An Outbreak of Hepatitis in a Diabetic Clinic re General and Plastic Surgery Devices; Reclassification of Blood Lancets Supporting & Related Material Background Material 2016-03-07T05:00:00Z 2016 3     2016-03-07T16:55:49Z   0 0 0900006481e9ee76
FDA-2016-N-0400-0001 FDA None FDA-2016-N-0400 General and Plastic Surgery Devices; Reclassification of Blood Lancets Proposed Rule Notice of Proposed Rulemaking (NPRM) 2016-03-03T05:00:00Z 2016 3 2016-03-03T05:00:00Z 2016-06-02T03:59:59Z 2016-06-02T13:00:23Z 2016-04578 0 0 0900006481e9bca4

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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;