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  • 1.  GUDID account Class II

    Posted 05-Jan-2016 22:00

    Hello, 

    Has anyone been able to request/obtain a GUDID account for Class II devices? When trying to request one in Dec 2015, I was informed by the helpdesk that accounts for Class II device manufacturers will only be available in 2016.

    Thanks.

    Ajay

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    Ajay Bhatia
    Salt Lake City UT
    United States
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  • 2.  RE: GUDID account Class II

    Posted 06-Jan-2016 08:59
    You can now login in and set up an GUDID account for a class II device and you will get an account set up however I do not think you can get access to start entering data yet. I was able to navigate around inside GUDID for some things such as finding a temporary GMDN number for the product which most companies cannot get unless they become members of the GMDN Organization. FDA has provided a list of temporary numbers that manufacturers can use (4 digit number) that can be entered in the appropriate block on the GUDID data template.

    Larry Petersen
    Regulatory Affairs Consultant



    Original Message


  • 3.  RE: GUDID account Class II

    Posted 07-Jan-2016 15:29

    Are you sure you were able to create an account? When requested through the UDI help desk, the New Account Request form still states the following:

    "At this time, we only accept account requests from labelers of class III medical devices, devices licensed under the Public Health Service Act (PHS Act), Implantable, Life-Supporting, or Life Sustaining devices.

    Are you a Labeler for a currently marketed device that meets these criteria?"

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    Brandon Bell
    Columbia SC
    United States

    Original Message


  • 4.  RE: GUDID account Class II

    Posted 07-Jan-2016 16:36

    Here's a link to the FDA workshop for class II:

    CDRH Industry Basics Workshop - Unique Device Identification (UDI), January 27, 2016

    Fda remove preview
     
    CDRH Industry Basics Workshop - Unique Device Identification (UDI), January 27, 2016
    Summary: This workshop (presented by webinar) will provided information on the fundamental concepts of Unique Device Identification and how to prepare for and request a GUDID account. The workshop features two sessions, each consisting of a presentation followed by a question and answer session with a panel of experts from the Office of Surveillance and Biometrics.
    View this on Fda >

    Hope that helps,

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    Clarisa Tate
    Medical Device, RA & QA
    Bay Area, CA
    USA

    Original Message


  • 5.  RE: GUDID account Class II

    Posted 08-Jan-2016 08:56

    Good morning,

    I have the same issue.  I sent a request for a GUDID account and the email stated that at this moment they are only accepting account request for two types of scenario, quoting:

    "At present there are two environments for the GUDID:

    Production environment:

    • This environment is currently ONLY open to labelers of Class III devices, devices licensed under the PHS Act, and devices that are implantable, life-supporting, or life-sustaining.
    • Labelers can submit to this environment through the web. They may also submit to the production environment using HL7 SPL after completing testing in the pre-production environment (see below).

    Pre-Production environment:

    • This environment is open to Labelers of Class III devices; devices licensed under the PHS Act; devices that are implantable, life-supporting, or life-sustaining; and third parties wishing to test the HL7 SPL submission option.
    • All data entered considered test only and will not fulfill GUDID submission requirements.
    • ALL LABELERS WHO WISH TO USE THE HL7 SPL SUBMISSION OPTION MUST FIRST GET AN ACCOUNT IN THE PRE-PRODUCTION ENVIRONMENT AND COMPLETE TESTING BEFORE THEY WILL BE GRANTED A PRODUCTION ACCOUNT."
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    Valeria Sena-Weltin, M.S., RAC(US)
    Regulatory Affairs Specialist
    Gaithersburg, MD

    Original Message