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  • 1.  MDUFA establishment registration

    Posted 23-Oct-2017 12:04
    Hello Guys,

    I have a question in regards to establishment registration of medical device facility.

    Currently we are only specification developer, and paid $3382 last year for our facility, but from coming next year we are going to be specification developer and complaint handler both, should we need to pay fees only $4624(FY2018) for both activities or it will be $4624 for just one activity?

    Any suggestion to this query will be highly appreciated.

    Thanks

    ------------------------------
    Shahid Hussain
    MCPHS University
    Allston MA
    United States
    ------------------------------


  • 2.  RE: MDUFA establishment registration

    Posted 24-Oct-2017 09:20
    Hello Shahid,

    The MDUFA fee is per establishment register not per activity or the number of devices listed. One company equals one <g class="gr_ gr_89 gr-alert gr_spell gr_disable_anim_appear ContextualSpelling ins-del multiReplace" id="89" data-gr-id="89">userfee</g>. 

    Best,

    Marc

    ------------------------------
    Marc Sanchez
    Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
    FDA Atty Law Firm (CIHCC, LLC)
    Charlotte NC
    United States
    ------------------------------

    Original Message


  • 3.  RE: MDUFA establishment registration

    Posted 24-Oct-2017 09:42

    The Establishment Registration fee is per facility, not per activity. The fee is the same no matter how many activities your facility lists.

     

    Regards,

    Beth

    ~~~~~~~~~~

    Beth Blevins
    Principal Regulatory Operations Specialist

    Medtronic

    Cardiac and Vascular Group/Coronary Structural Heart RA

    707.591.2787 office

    707.738.6457 cell

    medtronic.com  |  Facebook  |  LinkedIn  |  Twitter  |  YouTube

     

    LET'S TAKE HEALTHCARE

    FURTHER, TOGETHER

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    Original Message


  • 4.  RE: MDUFA establishment registration

    Posted 24-Oct-2017 15:05
    Edited by Shahid Hussain 24-Oct-2017 15:05
    Thank you very much for your valuable advice.

    ------------------------------
    Shahid Hussain
    MCPHS University
    Allston MA
    United States
    ------------------------------

    Original Message


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