The Fact About Investigational New Drug (IND) Application That No One Is Suggesting
If the appropriate person cost hasn't been paid out and/or a valid eSTAR or eCopy has not been presented, then the FDA will email a Hold Letter to your 510(k) submitter, normally in just 7 times of receipt of your 510(k). The submitter then has 180 calendar times from the date of your Hold Letter to totally solve the issues While using the user fee