Regulatory News In Brief

510(k) user fee guidance: FDA will no longer refund 510(k) user fees paid for products that are later determined not to be a device or to be exempt from 510(k) review, according to Aug. 27 1guidance on 510(k) user fees and refunds. The prior 2004 guidance said FDA would refund fees in such instances. The new guidance says it is the company's responsibility to review the regulations and determine whether a product is a device and whether it is 510(k)-exempt. FDA will only refund user fees mistakenly paid for the following 510(k) submissions that are statutorily exempt from the fee: submissions reviewed and submitted by FDA-accredited third parties, submissions for devices intended solely for pediatric patients, and submissions by state or federal government entities with no intent to commercialize. FDA updated its user fee guidance for PMA devices in March (2"The Gray Sheet" March 23, 2009)