The Definitive Guide to and Control (CMC)
If the right user cost hasn't been compensated and/or a valid eSTAR or eCopy has not been offered, then the FDA will e-mail a Maintain Letter to your 510(k) submitter, generally inside of 7 times of receipt from the 510(k). The submitter then has a hundred and eighty calendar times through the date from the Hold Letter to fully resolve the problems