Regulatory Open Forum

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  • 1.  HDE Application/HUD Submission

    Posted 07-May-2015 12:57
    Does anyone happen to have proven acceptable templates to be used for Humaitarian Device Exemption (HDE) application and the resulting Humanitarian Use Device (HDE) submission. Thanks in advance for your help.

    Humanitarian Device

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    Robert Wilkinson
    President
    Resolute Regulatory Affairs Consulting Service, Inc
    Port Barrington IL
    United States
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  • 2.  RE:HDE Application/HUD Submission

    Posted 08-May-2015 02:16
    Hi Robert,

    I was putting together an HDE package together for a non-pediatric device last year. Unfortunately, the project got canceled. The best thing for you to do is reach out to Eric Chen at OOPD. He was really helpful and provided guidance.
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    Mark Paquin RAC
    Product Development, Clinical, and Regulatory Affairs Consultant
    Medical Products Market Consulting
    Miami Beach FL
    United States
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    Original Message


  • 3.  RE: HDE Application/HUD Submission

    Posted 08-May-2015 09:06
    Bob,

    PMA/HDE/HUD templates are available from Global Compliance Seminar at  http://globalcomplianceseminar.com/

    510(k) templates are also available from GCS at http://wp.me/P2EoXX-KO

    For anyone interested in learning more about the templates, you may contact me at david@regulatorydoctor.com 

    The templates have been developed based on many similar, actual cases/applications.  


    Original Message