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  • 1.  FDA regulation for license transfer

    Posted 18-Jun-2018 15:32

    Is there an FDA guidance or resource that can help with the process of transferring a license from one sponsor to another (timelines, regulations, fees, etc.)?

    Thanks,

    Tolu



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    Toluwalope Cole Badejo

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  • 2.  RE: FDA regulation for license transfer

    Posted 19-Jun-2018 10:52

    It's not clear what kind of FDA license you are referring to, but for a 510(k) refer to guidance at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM427385.pdf

     




    Original Message


  • 3.  RE: FDA regulation for license transfer

    Posted 20-Jun-2018 11:00

    Do a search for this title on the FDA web site:

     

    Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers

     

    Thanks

     

    Al Van Houdt, RAC

    Sr. Mgr. Regulatory Affairs & Compliance

     

    Spacelabs Healthcare

    o 425-363-5970

    m 425-281-7683

    Fax 425-363-5762

    www.spacelabshealthcare.com

     

     




    Original Message


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