Regulatory Open Forum

 View Only

  • 1.  Hand-Delivering 510k

    Posted 27-Mar-2012 10:18
    Has anybody hand-delivered a 510(k) to the FDA?

    I was wondering if there is a specific process for doing so, or is it simply finding the Document Mail Center and dropping the 510(k) package off?

    Thanks!

    -------------------------------------------
    Elaine Chang
    Regulatory Affairs Specialist
    Knoxville TN
    United States
    -------------------------------------------