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FAQs about Process Overview - Medical Device User Fee

Posted Date:2019/1/30

Process Overview - Medical Device User Fee

1. Where can I find more information about the MDUFA?

Click here for information and guidance documents about the Medical Device User Fee program.

2.  Why does the Food and Drug Administration (FDA) require a cover sheet?

The FDA requests cover sheets to link your user fee payment with your application submission.  Review of an application submission by the FDA cannot begin until the fee has been paid in full.  Form FDA 3601, the Medical Device User Fee cover sheet, is designed to provide the minimum necessary information to determine whether a fee is required for review of an application submission, to determine the amount of the fee required, and to help the FDA track payments. 

Note: The review of the application submission will NOT begin UNTIL the bank receives your payment AND the FDA is notified by a receipt from the bank stating that your payment has been received and processed.