{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2016-N-0400\" sorted by posted_date descending", "rows": [["FDA-2016-N-0400-0191", "FDA", "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", null, "2021-11-22T15:51:30Z", "2021-25376", 0, 0, "0900006484e71279"], ["FDA-2016-N-0400-0182", "FDA", "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", null, "2016-06-01T21:03:08Z", null, 0, 0, "0900006482006a50"], ["FDA-2016-N-0400-0003", "FDA", "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, null, null, "2016-03-07T16:50:54Z", null, 0, 0, "0900006481e9edc4"], ["FDA-2016-N-0400-0006", "FDA", "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, null, null, "2016-03-07T16:52:21Z", null, 0, 0, "0900006481e9edc7"], ["FDA-2016-N-0400-0041", "FDA", "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, null, null, "2016-03-07T17:11:50Z", null, 0, 0, "0900006481e9f116"], ["FDA-2016-N-0400-0025", "FDA", "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, null, null, "2016-03-07T17:04:36Z", null, 0, 0, "0900006481e9eccb"], ["FDA-2016-N-0400-0016", "FDA", "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, null, null, "2016-03-07T16:56:30Z", null, 0, 0, "0900006481e9ee78"], ["FDA-2016-N-0400-0039", "FDA", "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, null, null, "2016-03-07T17:11:15Z", null, 0, 0, "0900006481e9f114"], ["FDA-2016-N-0400-0029", "FDA", "FDA-2016-N-0400", "Reference 27 - \u201cNever Events\u201d 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, null, null, "2016-03-07T17:06:10Z", null, 0, 0, "0900006481e9ece5"], ["FDA-2016-N-0400-0004", "FDA", "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, null, null, "2016-03-07T16:51:28Z", null, 0, 0, "0900006481e9edc5"], ["FDA-2016-N-0400-0035", "FDA", "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, null, null, "2016-03-07T17:08:38Z", null, 0, 0, "0900006481e9eceb"], ["FDA-2016-N-0400-0005", "FDA", "FDA-2016-N-0400", "Reference 3 - FDA\u2019s 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, null, null, "2016-03-07T16:51:53Z", null, 0, 0, "0900006481e9edc6"], ["FDA-2016-N-0400-0022", "FDA", "FDA-2016-N-0400", "Reference 20 - Transmission of Hepatitis B Virus Among Persons Undergoing Blood Glucose Monitoring in Long-Term-Care Facilities \u2013 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, null, null, "2016-03-07T17:03:43Z", null, 0, 0, "0900006481e9ecc8"], ["FDA-2016-N-0400-0023", "FDA", "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, null, null, "2016-03-07T17:03:57Z", null, 0, 0, "0900006481e9ecc9"], ["FDA-2016-N-0400-0042", "FDA", "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, null, null, "2016-03-07T17:12:11Z", null, 0, 0, "0900006481e9f117"], ["FDA-2016-N-0400-0021", "FDA", "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, null, null, "2016-03-07T17:02:03Z", null, 0, 0, "0900006481e9ecc7"], ["FDA-2016-N-0400-0024", "FDA", "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, null, null, "2016-03-07T17:04:13Z", null, 0, 0, "0900006481e9ecca"], ["FDA-2016-N-0400-0027", "FDA", "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 \u2013Living 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, null, null, "2016-03-07T17:05:29Z", null, 0, 0, "0900006481e9eccd"], ["FDA-2016-N-0400-0008", "FDA", "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, null, null, "2016-03-07T16:53:12Z", null, 0, 0, "0900006481e9ee70"], ["FDA-2016-N-0400-0011", "FDA", "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, null, null, "2016-03-07T16:54:41Z", null, 0, 0, "0900006481e9ee73"], ["FDA-2016-N-0400-0009", "FDA", "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, null, null, "2016-03-07T16:53:48Z", null, 0, 0, "0900006481e9ee71"], ["FDA-2016-N-0400-0015", "FDA", "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, null, null, "2016-03-07T16:56:08Z", null, 0, 0, "0900006481e9ee77"], ["FDA-2016-N-0400-0017", "FDA", "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, null, null, "2016-03-07T16:56:51Z", null, 0, 0, "0900006481e9ee79"], ["FDA-2016-N-0400-0030", "FDA", "FDA-2016-N-0400", "Reference 28 - Transmission of HBV Among Assisted-Living-Facility Residents \u2013 Virginia, 2012 re General and Plastic Surgery Devices; Reclassification of Blood Lancets", "Supporting & Related Material", "Background Material", "2016-03-07T05:00:00Z", 2016, 3, null, null, "2016-03-07T17:06:45Z", null, 0, 0, "0900006481e9ece6"], ["FDA-2016-N-0400-0031", "FDA", "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, null, null, "2016-03-07T17:07:15Z", null, 0, 0, "0900006481e9ece7"], ["FDA-2016-N-0400-0020", "FDA", "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, null, null, "2016-03-07T16:59:04Z", null, 0, 0, "0900006481e9ecc6"], ["FDA-2016-N-0400-0028", "FDA", "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, null, null, "2016-03-07T17:05:50Z", null, 0, 0, "0900006481e9ece4"], ["FDA-2016-N-0400-0037", "FDA", "FDA-2016-N-0400", "Reference 34 - Increasing Prevalence of Diagnosed Diabetes \u2014 United States and Puerto Rico, 1995\u20132010 re General and Plastic Surgery Devices; Reclassification of Blood Lancets", "Supporting & Related Material", "Background Material", "2016-03-07T05:00:00Z", 2016, 3, null, null, "2016-03-07T17:10:44Z", null, 0, 0, "0900006481e9eced"], ["FDA-2016-N-0400-0007", "FDA", "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, null, null, "2016-03-07T16:52:46Z", null, 0, 0, "0900006481e9edc8"], ["FDA-2016-N-0400-0013", "FDA", "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, null, null, "2016-03-07T16:55:29Z", null, 0, 0, "0900006481e9ee75"], ["FDA-2016-N-0400-0040", "FDA", "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, null, null, "2016-03-07T17:11:29Z", null, 0, 0, "0900006481e9f115"], ["FDA-2016-N-0400-0026", "FDA", "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 \u2013 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, null, null, "2016-03-07T17:05:05Z", null, 0, 0, "0900006481e9eccc"], ["FDA-2016-N-0400-0032", "FDA", "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, null, null, "2016-03-07T17:07:36Z", null, 0, 0, "0900006481e9ece8"], ["FDA-2016-N-0400-0033", "FDA", "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, null, null, "2016-03-07T17:07:53Z", null, 0, 0, "0900006481e9ece9"], ["FDA-2016-N-0400-0036", "FDA", "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, null, null, "2016-03-07T17:10:30Z", null, 0, 0, "0900006481e9ecec"], ["FDA-2016-N-0400-0010", "FDA", "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, null, null, "2016-03-07T16:54:13Z", null, 0, 0, "0900006481e9ee72"], ["FDA-2016-N-0400-0012", "FDA", "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, null, null, "2016-03-07T16:55:04Z", null, 0, 0, "0900006481e9ee74"], ["FDA-2016-N-0400-0038", "FDA", "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, null, null, "2016-03-07T17:10:57Z", null, 0, 0, "0900006481e9f113"], ["FDA-2016-N-0400-0002", "FDA", "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, null, null, "2016-03-07T16:50:26Z", null, 0, 0, "0900006481e9edc3"], ["FDA-2016-N-0400-0034", "FDA", "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, null, null, "2016-03-07T17:08:06Z", null, 0, 0, "0900006481e9ecea"], ["FDA-2016-N-0400-0018", "FDA", "FDA-2016-N-0400", "Reference 16- Nosocomial Hepatitis B Virus Infection Associated with Reusable Fingerstick Blood Sampling Devices \u2013 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, null, null, "2016-03-07T16:57:18Z", null, 0, 0, "0900006481e9ecc4"], ["FDA-2016-N-0400-0019", "FDA", "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, null, null, "2016-03-07T16:58:18Z", null, 0, 0, "0900006481e9ecc5"], ["FDA-2016-N-0400-0014", "FDA", "FDA-2016-N-0400", "Reference 12 - 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