Extract to table

The statute does not permit an applicant to look solely at its own standalone revenue; rather, the revenues of the applicant and all affiliates must be aggregated and measured against the threshold on a consolidated basis

Similarly, two or more commonly owned entities must combine their revenues for purposes of the calculation, even if each entity independently falls below the threshold

The qualification decision is generally valid for the fiscal year in which it is issued, and applicants must recertify annually if they wish to maintain small business status for subsequent submissions

Fee Payment Timing The 510(k) user fee must be paid at the time of submission