The 5-Second Trick For CCC Mark Approval
If the right user fee has not been compensated and/or a sound eSTAR or eCopy hasn't been delivered, then the FDA will email a Hold Letter into the 510(k) submitter, typically inside seven days of receipt from the 510(k). The submitter then has one hundred eighty calendar days from the day in the Keep Letter to totally take care of the problems Usin