Regulatory Open Forum

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  • 1.  Submissions to CDRH during COVID

    Posted 12-Oct-2021 14:43
    Hi Everyone,

    I haven't had to submit an IDE to CDRH during COVID.  How are they taking submissions? Previously, I have mailed in submissions but wasn't sure if they created something similar to the NextGen Portal used for IND submissions.  Thanks!

    Lauren Kanigher
    FDA Program Manager
    Richmond VA
    United States

  • 2.  RE: Submissions to CDRH during COVID

    Posted 13-Oct-2021 08:54

    You will still submit via mail/FedEx/UPS etc. The content will be on a disc/thumb drive with just a paper cover letter (no other paper documents). Check the current eCopy guidance:


    David Jensen PhD, RAC
    Regulatory Affairs Scientist
    Durham NC
    United States