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withdrawn,object_id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-M-0035-0045,FDA,FDA-2016-M-0035,"Effective Date of Requirement for
Premarket Approval for Blood Lancets",Rule,Final Rule,2021-11-22T05:00:00Z,2021,11,2021-11-22T05:00:00Z,,2021-11-22T15:54:18Z,2021-25381,0,0,0900006484e71390
FDA-2016-M-0035-0023,FDA,FDA-2016-M-0035,Reference 21 - Point-of-Care Blood Glucose Testing for Diabetes Care in Hospitalized Patients An Evidence-Based Review re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:28:39Z,,0,0,0900006481e9da7a
FDA-2016-M-0035-0026,FDA,FDA-2016-M-0035,Reference 24 - Deja Vu: Nosocomial Hepatitis B Transmission and Fingerstick Monitoring re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:30:48Z,,0,0,0900006481e9da7d
FDA-2016-M-0035-0012,FDA,FDA-2016-M-0035,Reference 10 - Transmission of Hepatitis B Infection During Home Blood Glucose Monitoring re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:21:44Z,,0,0,0900006481e9ddc2
FDA-2016-M-0035-0034,FDA,FDA-2016-M-0035,"Reference 32 - Deaths from Acute Hepatitis B Virus Infection Associated with Assisted Blood Glucose Monitoring in an Assisted –Living Facility-North Carolina, August--October 2010 re Effective Date of Requirement for Premarket Approval for Blood Lancets",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:36:22Z,,0,0,0900006481e9ddfa
FDA-2016-M-0035-0039,FDA,FDA-2016-M-0035,"Reference 37 - Transmission of HBV Among Assisted-Living-Facility Residents – Virginia, 2012 re Effective Date of Requirement for Premarket Approval for Blood Lancets",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:38:21Z,,0,0,0900006481e9ddff
FDA-2016-M-0035-0005,FDA,FDA-2016-M-0035,"Reference 3 - FDA’s General and Plastic Surgery Devices Panel transcript and other meeting materials for the June 26, 2013 meeting re Effective Date of Requirement for Premarket Approval for Blood Lancets",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:18:12Z,,0,0,0900006481e9d9c7
FDA-2016-M-0035-0008,FDA,FDA-2016-M-0035,Reference 6 - History of Viral Hepatitis -A Tale of Dogmas and Misinterpretations re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:19:33Z,,0,0,0900006481e9d9cc
FDA-2016-M-0035-0027,FDA,FDA-2016-M-0035,"Reference 25 - Nonhospital Health Care-Associated Hepatitis B and C Virus Transmission: United States, 1998-2008 re Effective Date of Requirement for Premarket Approval for Blood Lancets",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:31:23Z,,0,0,0900006481e9da7e
FDA-2016-M-0035-0019,FDA,FDA-2016-M-0035,"Reference 18 -Incidence of Diagnosed Diabetes per 1,000 Population Aged 18-79 Years, 1980-2014 re Effective Date of Requirement for Premarket Approval for Blood Lancets",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:25:59Z,,0,0,0900006481e9ddc9
FDA-2016-M-0035-0029,FDA,FDA-2016-M-0035,"Reference 27 - Transmission of Hepatitis B Virus Among Persons Undergoing Blood Glucose Monitoring in Long-Term-Care Facilities – Mississippi, North Carolina, 2003--2004 re Effective Date of Requirement for Premarket Approval for Blood Lancets",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:32:54Z,,0,0,0900006481e9da80
FDA-2016-M-0035-0011,FDA,FDA-2016-M-0035,Reference 9 - Transmission of Hepatitis B During Blood Glucose Monitoring re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:21:13Z,,0,0,0900006481e9ddc1
FDA-2016-M-0035-0018,FDA,FDA-2016-M-0035,Reference 16 - Contamination of a Fingerstick Device re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:25:05Z,,0,0,0900006481e9ddc8
FDA-2016-M-0035-0038,FDA,FDA-2016-M-0035,Reference 36 - Survey and Certification Memorandum re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:37:59Z,,0,0,0900006481e9ddfe
FDA-2016-M-0035-0024,FDA,FDA-2016-M-0035,Reference 22 - Use of Hepatitis B Vaccination for Adults with Diabetes Mellitus Recommendations of the Advisory Committee on Immunization Practices (ACIP) re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:30:11Z,,0,0,0900006481e9da7b
FDA-2016-M-0035-0035,FDA,FDA-2016-M-0035,Reference 33 - Infection Control Assessment of Ambulatory Surgical Centers re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:36:46Z,,0,0,0900006481e9ddfb
FDA-2016-M-0035-0002,FDA,FDA-2016-M-0035,LIST OF REFERENCES to Blood Lancets Call for PMAs re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:16:28Z,,0,0,0900006481e9d917
FDA-2016-M-0035-0003,FDA,FDA-2016-M-0035,Reference 1 - Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:17:35Z,,0,0,0900006481e9d9c5
FDA-2016-M-0035-0004,FDA,FDA-2016-M-0035,Reference 2 - Blood Lancet Labeling re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:17:52Z,,0,0,0900006481e9d9c6
FDA-2016-M-0035-0007,FDA,FDA-2016-M-0035,Reference 5 - Viral Hepatitis Transmission in Ambulatory Health Care Settings re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:19:02Z,,0,0,0900006481e9d9c9
FDA-2016-M-0035-0025,FDA,FDA-2016-M-0035,"Reference 23- Nosocomial Hepatitis B Virus Infection Associated with Reusable Fingerstick Blood Sampling Devices – Ohio and New York City, 1996 re Effective Date of Requirement for Premarket Approval for Blood Lancets",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:30:28Z,,0,0,0900006481e9da7c
FDA-2016-M-0035-0013,FDA,FDA-2016-M-0035,Reference 11 - Fulminant Hepatic Failure Due to Acute Hepatitis B and Delta Co-Infection Probable Bloodborne Pathogen Transmission Associated with a Spring-loaded Fingerstick Device re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:22:01Z,,0,0,0900006481e9ddc3
FDA-2016-M-0035-0010,FDA,FDA-2016-M-0035,Reference 8 - An Outbreak of Hepatitis in a Diabetic Clinic re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:20:43Z,,0,0,0900006481e9d9ce
FDA-2016-M-0035-0022,FDA,FDA-2016-M-0035,Reference 20 - Glucose Biosensors An Overview of Use in Clinical Practice re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:28:09Z,,0,0,0900006481e9da79
FDA-2016-M-0035-0014,FDA,FDA-2016-M-0035,Reference 12 - Epidemiologic Notes and Reports Nosocomial Transmission of Hepatitis B Virus Associated with a Spring-Loaded Fingerstick Device-California re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:22:29Z,,0,0,0900006481e9ddc4
FDA-2016-M-0035-0031,FDA,FDA-2016-M-0035,"Reference 29 - Evaluation of the Potential for Bloodborne Pathogen Transmission Associated with Diabetes Care Practices in Nursing Homes and Assisted Living Facilities, Pinellas County re Effective Date of Requirement for Premarket Approval for Blood Lancets",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:33:47Z,,0,0,0900006481e9ddf7
FDA-2016-M-0035-0006,FDA,FDA-2016-M-0035,Reference 4 - Five Hepatitis B Outbreaks in Care Homes in the UK Associated with Deficiencies in Infection Control Practice in Blood Glucose Monitoring re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:18:35Z,,0,0,0900006481e9d9c8
FDA-2016-M-0035-0021,FDA,FDA-2016-M-0035,Reference 19 - A History of Blood Glucose Meters and Their Role in Self-Monitoring of Diabetes Mellitus re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:27:13Z,,0,0,0900006481e9da78
FDA-2016-M-0035-0016,FDA,FDA-2016-M-0035,Reference 14 - Nosocomial Transmission of Hepatitis B Virus Associated with the Use of a Spring-Loaded Fingerstick Device re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:24:01Z,,0,0,0900006481e9ddc6
FDA-2016-M-0035-0032,FDA,FDA-2016-M-0035,Reference 30 - . Infection Control Practices in Assisted Living Facilities A Response to Hepatitis B Virus Infection Outbreaks re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:35:37Z,,0,0,0900006481e9ddf8
FDA-2016-M-0035-0033,FDA,FDA-2016-M-0035,"Reference 31 - Multiple Outbreaks of Hepatitis B Virus Infection Related to Assisted Monitoring of Blood Glucose Among Residents of Assisted Living Facilities – Virginia, 2009-2011 re Effective Date of Requirement for Premarket Approval for Blood Lancets",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:35:55Z,,0,0,0900006481e9ddf9
FDA-2016-M-0035-0036,FDA,FDA-2016-M-0035,"Reference 34 - “Never Events” Hepatitis B Outbreaks and patient Notifications Resulting from Unsafe Practices during Assisted Monitoring of Blood Glucose, 2009-2010 re Effective Date of Requirement for Premarket Approval for Blood Lancets",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:37:04Z,,0,0,0900006481e9ddfc
FDA-2016-M-0035-0028,FDA,FDA-2016-M-0035,Reference 26 - Nosocomial Transmission of Hepatitis B Virus Infection Among Residents with Diabetes in a Skilled Nursing Facility re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:32:29Z,,0,0,0900006481e9da7f
FDA-2016-M-0035-0030,FDA,FDA-2016-M-0035,Reference 28 - Eliminating the Blood Outbreaks of Hepatitis B Virus Infection and the Need for Innovative Glucose Monitoring Technologies re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:33:18Z,,0,0,0900006481e9da81
FDA-2016-M-0035-0037,FDA,FDA-2016-M-0035,Reference 35 - Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:37:31Z,,0,0,0900006481e9ddfd
FDA-2016-M-0035-0009,FDA,FDA-2016-M-0035,Reference 7 - Diabetes Mellitus A Survey of Changes in Treatment During the Last Fifteen Years re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:20:08Z,,0,0,0900006481e9d9cd
FDA-2016-M-0035-0041,FDA,FDA-2016-M-0035,Reference 39 - An Outbreak of Nosocomial Hepatitis B Virus Infection in a Nursing Home for the Elderly in Antwerp (Belgium) re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:39:08Z,,0,0,0900006481e9dac5
FDA-2016-M-0035-0015,FDA,FDA-2016-M-0035,Reference 13 - Safety Alert Medical Devices; Hepatitis B Transmission via Spring-Loaded Lancet Devices re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:23:21Z,,0,0,0900006481e9ddc5
FDA-2016-M-0035-0017,FDA,FDA-2016-M-0035,Reference 15 - An Outbreak of Hepatitis B in an Endocrinology Unit Traced to a Capillary Blood Sampling Device re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:24:26Z,,0,0,0900006481e9ddc7
FDA-2016-M-0035-0040,FDA,FDA-2016-M-0035,Reference 38 - Hepatitis C in a Ward for Cystic Fibrosis and Diabetic Patients Possible Transmission by Spring-Loaded Finger-Stick Devices for Self-Monitoring of Capillary Blook Glucose re Effective Date of Requirement for Premarket Approval for Blood Lancets,Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:38:47Z,,0,0,0900006481e9de00
FDA-2016-M-0035-0042,FDA,FDA-2016-M-0035,"Reference 40 - 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 Effective Date of Requirement for Premarket Approval for Blood Lancets",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:39:26Z,,0,0,0900006481e9dac6
FDA-2016-M-0035-0020,FDA,FDA-2016-M-0035,"Reference 17 - Increasing Prevalence of Diagnosed Diabetes – United States and Puerto Rico, 1995-2010 re Effective Date of Requirement for Premarket Approval for Blood Lancets",Supporting & Related Material,Background Material,2016-03-07T05:00:00Z,2016,3,,,2016-03-07T16:26:39Z,,0,0,0900006481e9ddca
FDA-2016-M-0035-0001,FDA,FDA-2016-M-0035,Effective Date of Requirement for Premarket Approval for 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,2016-06-02T01:01:08Z,2016-04579,0,0,0900006481e9bb71