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

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43 rows where docket_id = "FDA-2016-M-0035" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-M-0035-0045 FDA None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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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;