If you make a written request within 180 days after the fee was due (see § 738(j)), FDA will refund 75% of a paid fee if we refuse to file a submission, or if the applicant withdrew a submission prior to our filing decision. § 738(a)(1)(D)(i) and (ii). If an applicant withdraws a premarket application, premarket report, or supplement after filing, but before a first action, FDA may, but is not required to, refund any portion of the fee, based on the level of effort already expended. FDA’s decision to make or refuse a refund after filing, and our determination of the amount of any refund, is not reviewable. § 738(a)(1)(D)(iii). FDA will not refund any portion of a fee following a first action. If an applicant resubmits an application that FDA refused to file, or which the applicant withdrew, a new fee (full amount) must be paid. | 
