The Greatest Guide To Investigational Device Exemption (IDE) Applications
If the appropriate user charge hasn't been paid out and/or a legitimate eSTAR or eCopy hasn't been supplied, then the FDA will e-mail a Hold Letter towards the 510(k) submitter, normally within seven times of receipt of the 510(k). The submitter then has one hundred eighty calendar times within the date from the Maintain Letter to totally take care