- November 20, 2016
07:00 PM - 07:00 PM EST
On Monday, November 21, 2016, the FDA hosted a 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, 2106, 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.
Target audience: Industry
If you have any general questions about the FDA’s regulation of medical devices, please contact CDRH’s Division of Industry and Consumer Education (DICE) at firstname.lastname@example.org, 1-800-638-2041, or 301-796-
Food and Drug Administration
Center for Devices and Radiological Health