Helping The others Realize The Advantages Of Premarket Notification 510(k)
If the right consumer rate hasn't been compensated and/or a legitimate eSTAR or eCopy has not been offered, then the FDA will e mail a Hold Letter to the 510(k) submitter, generally in 7 days of receipt of your 510(k). The submitter then has 180 calendar days through the day on the Hold Letter to fully resolve the problems Together with the person