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Guidance for Industry and Food and Drug Administration Staff - Blood Lancet Labeling

Mon, 11/29/2010 - 4:39am
U.S. Food & Drug Administration

For questions regarding this document contact Sheila A. Murphey, MD, 301-796-6302, sheila.murphey@fda.hhs.gov or Neil Ogden, 301-796-6397, neil.ogden@fda.hhs.gov.

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U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Office of Device Evaluation

Division of Surgery, Orthopedic and Restorative Devices

Preface

  1. Centers for Disease Control and Prevention. 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. MMWR 2005; 54: 220-223
  2. Patel AS, White-Comstock MB, Woolard D, Perz JF. Infection Control Practices in Assisted Living facilities: A Response to Hepatitis B Virus Infection Outbreaks. ICHE 2009; 30(3): 209-214
  3. Thompson ND, Perz JF. Eliminating the Blood: Ongoing Outbreaks of Hepatitis B Virus Infection and the Need for Innovative Glucose Monitoring Technologies. J Diabetes Sci Technol 2009; 3 (2): 283-288
  4. Thompson ND, Perz JF, Moorman AC, Holmberg SD. Nonhospital Health Care-Associated Hepatitis B and C Virus transmission: United States, 1998-2008. Ann Int Med 2009; 150: 33-39
  5. Labeling reusable medical devices for reprocessing in health care facilities: FDA reviewer guidance (1996). http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm080268.pdf

* Any setting where fingerstick procedures are performed, including assisted living or residential care facilities, skilled nursing facilities, clinics, health fairs, shelters, detention facilities, senior centers, schools, and camps.

    

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