No, Section 738(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act states that all device
user fees are due upon submission of device reports (such as PMA annual report) or device
applications. A company must pay the fees before submitting their reports or applications.
The process requires an applicant to first submit (and receive) the small business
certification, and then submit any user fee-requiring applications in order to obtain the
reduced fee. We have no provision for an applicant to retroactively request a small business
status for a prior FY.
