IRISH CALL FOR SMALL BUSINESS BENEFITS

The Irish Medical Devices Association (IMDA), which falls within the Irish Business and Employers Confederation, has called for "a concerted effort to be made across Europe" to establish a system to enable small European Union-based medical device and diagnostic companies to benefit from major reductions in fees when registering new product applications with the FDA.

Currently small U.S. companies qualify for fee reductions of 38 percent, the IMDA said, giving them "a massive competitive advantage over their European counterparts."

"The U.S. is the biggest export market for Irish companies," said IMDA Director Sharon Higgins.

Non-U.S. companies requiring premarket approval (PMA) from the FDA are missing out on potential savings of up to $260,000, according to IMDA. Under the Medical Device User Fee Modernization Act, firms submitting a PMA application to the FDA have to pay a fee of $259,600, IMDA said, adding that companies with annual gross sales of $30 million or less do not have to pay a fee for their first PMA filing, and those with gross sales of receipts of $100 million or receive a 38 percent reduction on fees.

"Non-U.S. companies are unable to apply because the current system requires that they submit federal income tax returns to show eligibility [for the fee reductions]," IMDA said.