US user fees: 510(k)s spared major hike as PMAs (Pre-market Approvals) rise 16%
This article was originally published in Clinica
Executive Summary
The US FDA is raising device user fees by 15.7% in all categories except 510(k)s in fiscal year 2005, the agency disclosed in a closed door meeting with industry last week. The increase for 510(k)s will be a mere 0.6%, bringing the fee to $3,502 for large companies and $2,802 for small companies.