Webinar: Blood Glucose Test Systems Final Guidance Documents
On Monday, November 21, 2016, from 11 a.m. to 12:30 pm ET, the FDA will host a stakeholder webinar to share information and answer questions about the final guidance documents Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use and Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use. Released on October 7, 2016, the purpose of these final guidance documents is to improve new blood glucose meters by providing FDA’s recommendations to industry about the types of information to be included in their premarket submissions (510(k)s) for these devices. The FDA believes that by making a distinction between different use settings, blood glucose meters can be better designed to meet the needs of their intended use populations.
For more information. Click here. No registration is required.
Helene D. Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration
Office of Health and Constituent Affairs
Food and Drug Administration
For more information about the Cardiovascular & Endocrine Liaison Program visit the FDA Patient Network
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