Since the Medical Device User Fee and Modernization Act of 2002, the FDA has charged device review user fees for 510(k) applications. FDA will adjust the fees each year to account for inflation, changes in workloads, and other factors. FDA will announce the new fees for the next fiscal year in a Federal Register notice by August 1 of each year.
The fee must be paid, unless the applicant is eligible for a waiver or exemption. Small businesses may qualify for a reduced fee. The determination of whether or not a company qualifies as a small business is based on the company’s Tax Return for the previous year. Non-US companies are also eligible for qualification as a 'small business'.
Payment must be received on or before the time any 510(k) is submitted. If the applicant has not paid all fees owed, FDA will consider the application incomplete and will not accept it for review.
GEMAR can assist you by : 
  • determining whether your company is eligible for an exemption;
  • helping you use the FDA on-line payment process; and
  • ensuring that the appropriate payment data is included in the PMA submission.