Regulatory Open Forum

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  • 1.  Yearly notifications to RA authorities

    Posted 17-Jan-2017 11:19
    Good morning,
    we know that Health Canada require medical device manufacturers to file a yearly notification of license renewal details, regardless of whether the design of the devices covered by the license has been modified with a significant change during the previous year. The manufacturer is required to notify Health Canada with any non-significant change applied to the device design.
    Is anybody aware of a similar requirement in the USA, please?
    Thank you for your answer

    ------------------------------
    Lorenzo Muratori
    Elekta
    West Sussex
    United Kingdom
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  • 2.  RE: Yearly notifications to RA authorities

    Posted 17-Jan-2017 17:09
    "Registration information must be submitted each year between October 1 and December 31, even if no changes have occurred. Listing information must be reviewed each year between October 1 and December 31, at the same time you review your registration information. Submit any updates at that time."

    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053181.htm#1

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 3.  RE: Yearly notifications to RA authorities

    Posted 18-Jan-2017 08:02
    Hi Lorenzo

    Julie referenced listing and facility registrations yearly requirement.  For 510(k) devices, that would be the only requirement at this time. In this update you might add additional modeks or catalogue numbers you think fall under your cleared 510(k), which do not require a new one. You would also poyemtially be updating manufacturing/testing facilities, which for 510(k) devices MIGHT not trigger a new 510(k) if the product design and technology and intended use did not change. At this time if you updated listings, you would update GUDID database.

    Class 3/PMA devices require an annual report to FDA in addition to registration and listing activities above. The annual report is required regardless of changes.

    Hope this is helpful.

    Best regards,

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC
    715-307-1850





    Original Message


  • 4.  RE: Yearly notifications to RA authorities

    Posted 19-Jan-2017 14:22
    Hi Lorenzo,
    To add onto Ginger's comment, if the device falls under the Electronic Product Radiation Control regulations it will likely require an annual report regardless of the regulation class. 21 CFR 1002.10 provides a table of devices and reporting requirements.

    Best

    ------------------------------
    Michael Nilo
    Network Regulatory Partners
    Nilo Medical Consulting Group
    Portland OR
    United States
    ------------------------------

    Original Message


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