Regulatory Open Forum

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  • 1.  Form FDA 3514 (CDRH Cover Sheet)

    Posted 22-Jun-2023 09:29
    I am not able to download the Form 3514 from FDA's website.  I'm using Adobe.   Is there a trick that I'm missing?   Thanks and regards,   MCM

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  • 2.  RE: Form FDA 3514 (CDRH Cover Sheet)

    Posted 22-Jun-2023 20:41

    Hello Michael

    If it's a plug-in problem, you'll need to download the form first, open the folder you've saved it in, and then open the file from there. (Adobe Reader is more capable when it's not running inside a browser.) If that still gives error messages, you may need to update your Adobe Reader version.

    https://www.fda.gov/media/72421/download



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    Anne LeBlanc
    United States
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  • 3.  RE: Form FDA 3514 (CDRH Cover Sheet)

    Posted 23-Jun-2023 04:27

    Michael,

    I have the same problem from time to time - even with the guidance documents.  It is a plug-in control or native file issue, so I usually Right-Click on the link, Save As, and then open from the saved folder and it works fine.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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