miércoles, 19 de octubre de 2016

CDRH Industry: FDA issues recommendations to improve blood glucose monitoring test systems

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On October 7, the U.S. Food and Drug Administration released two final guidance documents: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (e.g., home use) and Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use (e.g., hospital use). Their purpose is to improve new blood glucose meters by providing recommendations to manufacturers about the types of studies and information that should be included in premarket submissions (510(k)s) for these devices.
These guidance documents provide FDA’s recommendations to industry based on the specific needs and characteristics of two different intended use populations: people affected by diabetes who use home tests; and patients whose blood glucose levels are monitored by health care professionals in health care settings (e.g., hospitals, doctors’ offices, clinics, and nursing homes). The guidance for blood glucose meters for use in health care settings discusses the physiological variables that could interfere with the accuracy of a blood glucose reading, and encourages industry to consider such variables in the design of their devices. The guidance for home-use blood glucose meters discusses the different characteristics that could interfere with the accurate use of the device without professional oversight, and encourages industry to take those characteristics into account when designing their device.
Together, both guidance documents can improve the accuracy and safe use of blood glucose meters, giving health care providers and people affected by diabetes safe and effective tools to monitor and manage their blood glucose levels in health care settings and at home. The FDA is also reaching out to health care professionals, people affected by diabetes, and diabetes patient advocacy groups to provide these guidance documents and to explain how the adoption of these recommendations by industry will result in improved new devices and ultimately benefit these groups. 
We encourage manufacturers and providers to become familiar with these guidance documents and to consult the appropriate guidance when preparing 510(k)s for blood glucose meters for use at home or for use in a professional health care settings.
If you have any questions regarding these guidance documents, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or dice@fda.hhs.gov.
In addition, CDRH will hold a webinar for industry and other stakeholders on Monday, November 21, 2016, from 11 am to 12:30 pm (Eastern Time) to answer questions regarding these guidance documents. No registration is required.
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health