MDMA Concerned by Dramatic User Fee Increases

The Food and Drug Administration recently published the FY04 device user fee rates in the Federal Register. The new rates, associated with the Medical Device User Fee and Modernization Act (MDUFMA), take effect October 1, 2004. Fees for Pre-Market Approval Applications (PMAs) and PMA supplements rose over 34 percent. Original PMA fees increased from $154,000 to $206,811. Fees for pre-market notifications [510(k)’s] jumped 59.1 percent for companies with sales over $30 million and 27.3 percent for companies with less than $30 million in sales.