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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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