US Guidance Helps Small Firms Apply for Reduced User Fees

Small businesses that want to save money on fiscal 2009 medical device user fees, which become effective Oct. 1, can get some help from a guidance published recently by the FDA. The new guidance says small businesses may qualify for discounted rates of most 2009 user fees. To avoid a delay in the review of their applications, manufacturers should pay user fees before or at the time of submission. Small businesses must be qualified as such before paying a reduced small business fee, the agency says. Businesses that qualified for the small business discount in fiscal 2008 must re-qualify for 2009.