Guidance for Reduced User Fees
Small businesses that want to save money on fiscal 2009 medical device-user fees, which became effective Oct. 1, can get some help from a guidance published recently by the FDA. The 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. Businesses that qualified for the small business discount in fiscal 2008 must requalify for 2009.
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