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FDA UDI & GUDID

Discussion in 'US Medical Device Regulations' started by Vintage Goose, Oct 13, 2015.

  1. Vintage Goose

    Vintage Goose Active Member

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    Hi, Its 12 months before Class II devices will require UDI's. I went to register for a GUDID account on the FDA website, but the response is that the environment is only open to labelers for class III devices. Does anyone know when Class II products can be entered?
     
  2. Eileen

    Eileen New Member

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    I wasn't able to get a GUDID account until end of January or beginning of February of 2015 for our compliance date of September 2015 (for Class II implantables). So I suppose in your case it might be the same - expect some time in the beginning of 2016.
     
  3. Vintage Goose

    Vintage Goose Active Member

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    Thanks Eileen. I knew that trying to get UDI done, with plenty of time to spare, wouldn't work o_O
     
  4. Vintage Goose

    Vintage Goose Active Member

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    I heard from the GUDID Help-Desk over the weekend, they responded "The GUDID should open to Class II devices in January, 2016".

    Note the use of the word "should".............
     
  5. Stephen Chung

    Stephen Chung New Member

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    Hello~

    1. Does anybody know how to obtain GMDN Codes for free?

    2. What does "Device Packaged as Sterile" mean? Our glucose kit contains a meter, a vial of strips, a plastic bag of sterile lancets, and a lancing device. Would the inclusion of sterile lancets make the kit package a "Device Packaged as Sterile" or is it talking about something else?
     
  6. Steve Kent

    Steve Kent Member

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    As I pointed out on the old Elsmar site, the Australian TGA site (https://www.ebs.tga.gov.au/) publishes ATRG .pdf documents which give their GMDN numbers. For example put in “suction” in the search box and you will get lots of suction devices listed (click on the left hand box to bring up the document and the GMDN and definition is given at the bottom).
    WARNING!
    GMDNs can become obsolete, so only the most recent ATRG numbers could be trusted as being current (no absolute guarantee though). There is NO direct other way of getting “free” GMDNs. Note that when the new medical device EU Regulations are published (2016?) it looks like there will be a requirement to supply GMDNs (or their equivalent) gratis.
    Steve
     
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  7. Pads38

    Pads38 Member

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    FDA have a new (draft) guidance out covering UDI for what they call "convenience kits" which you may find is applicable. This gives some scope for limiting the need for UDI for such kits.

    See here:
    http://www.emergogroup.com/blog/2016/01/us-fda-revisits-udi-requirements-convenience-kits

    and
    http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM479242.pdf
     
  8. Vintage Goose

    Vintage Goose Active Member

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    To answer my own question..............

    I recently received an email from FDA saying that for Class II, (other than Implantable, Life-Supporting and Life-Sustaining Devices), CDRH will begin to accept Global Unique Device Identification Database (GUDID) account requests from 1st February 2016
     
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  9. Jim Hagenbaugh

    Jim Hagenbaugh Member

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