viernes, 18 de noviembre de 2016

CDRH Industry: Reminder: Webinar – 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

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On Monday, November 21, 2016, the FDA will host 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.
Webinar Details:
Registration not necessary
Date: Monday, November 21, 2016
Time: 11:00 am -12:30 pm, Eastern Time
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.
To hear the presentation and ask questions:
Dial in: 800-988-9456; passcode: 4609361 | International 1-630-395-0185; passcode: 4609361
On the day of the webinar, use the following link to view the presentation:
Conference number: PW1456148
Following the webinar, a transcript and the video recording will be available at:
NOTE: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance.
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, 1-800-638-2041, or 301-796-
Food and Drug Administration
Center for Devices and Radiological Health

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