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Advanced Medical Isotope Corporation Message Board

  • kayak_wench kayak_wench Dec 17, 2013 1:50 PM Flag

    FDA has performance goals associated with response to 510(k) applications

    Based on the goals we may hear something by Jan 4 since their intention is to provide 'Substantive Interaction' to 65% of applications in FY 2013. But it also shows that its acceptable for response to take longer then 90 days, at least for no more than 9% of the applications. I've tried to put in link, but can't post when I do. Do a Google search on "FDA plan new time frame for 510(k)" and the link should be the first returned. If they already hit their 65% goal we probably won't hear back even if its ready (i..e it will sit on a desck) so expectations of them for next year don't get raised too much.

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