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DOC conversation with FDA on Meter Accuracy Monday 3/31

Discussion in 'Parents of Children with Type 1' started by badshoe, Mar 27, 2014.

  1. badshoe

    badshoe Approved members

    Joined:
    Jun 28, 2006
    Messages:
    2,153
    From FDA: http://patientnetwork.fda.gov/get-involved/join-live-chat/ask-fda-diabetes-webinar

    Please join us for a Patient Network Live Chat!

    Diabetes: Glucose Monitors and Test Strips

    Talk with FDA expert Courtney Lias and Patient Advocate Bennet Dunlap about Glucose Monitors and Test Strips
    Monday, March 31, 1:30–2:30 pm (EDT)

    Talk, share, and connect with the FDA and the Diabetes Patient Community

    Enjoy an informal, open discussion with a fellow patient advocate, CDRH subject-matter-expert and others in the diabetes community.
    Learn more about the role of the Center for Devices and Radiological Health, specifically the Office of In Vitro Diagnostics and its work to ensure the safety and effectiveness of medical devices used in the management of diabetes.

    Get your questions answered about the newest FDA draft guidances, which are proposing new recommendations intended to improve the accuracy and safe use of blood glucose monitoring test systems, giving health care providers and people with diabetes better tools to manage blood glucose levels.
    Whether you want to just listen to the interview to get informed, ask relevant questions to better understand the medical device regulatory process or just speak your mind on the newest draft guidance document…. you should join in the conversation.

    Mark your calendars and be sure to join us on March 31st, 2014.


    More info and how to register:

    http://www.stripsafely.com/doc-to-interview-fda-on-meter-guidance/
     
  2. Jeff

    Jeff Founder, CWD

    Joined:
    Jun 1, 1995
    Messages:
    1,549
    Thanks Bennet -- this is critically important to all of us.
     
  3. badshoe

    badshoe Approved members

    Joined:
    Jun 28, 2006
    Messages:
    2,153
    Jeff and Friends

    FDA has posted a video of the conversation on their Patient Network
    http://patientnetwork.fda.gov/diabetes-live-chat
    I agree this is a critical issue. We have an opportunity to help FDA understand that families with CDWs want:
    • Consistently accurate meter systems.
    • Than once created all meters should rapidly be required to meet the new accuracy rules. AKA no grandfathering old devices.
    • Only new more accurate devices should be label to dose insulin and make therapy adjustments.
    These idea and more are in an easy to copy and paste draft, ready to be posted to FDA docket at:
    http://www.stripsafely.com/sample-page/guidance/

    Thanks Jeff and everyone else who has commented to FDA. There is still time for to join and help FDA help us!
     
  4. wilf

    wilf Approved members

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    Aug 27, 2007
    Messages:
    9,652
    When it comes to the technology, for many of us this is THE critical issue.

    Thank you so much for taking this on. :cwds:
     

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