FDA ISSUES GUIDANCE ON SMALL BUSINESS STATUS FOR FIRMS
The FDA posted guidance on how device firms can qualify for small business user fee discounts and waivers for agency reviews of their products under the Medical Device User Fee and Modernization Act in fiscal 2007.
Firms that reported less than $100 million in total gross receipts or sales on their federal income tax returns for the most recent tax year can qualify for small business fee discounts, the guidance states.
That $100 million total must include receipts and sales of affiliates, partners or parent firms, the agency noted.
A firm bringing in a total of $30 million or less can also qualify for a waiver of the user fee for its first premarket application, whether it is a premarket approval (PMA) application, a product development protocol, a biologic license application or a premarket report.
Firms can save from just over 50 percent to nearly 75 percent on their user fees if they are granted small business status by the FDA. For example:
The standard fee for premarket applications for fiscal 2007 is $281,600 versus the small business rate of $107,008;
The standard fee for a 180-day PMA supplement is $60,554 versus the small business rate of $23,007; and
The standard rate for a real-time PMA supplement is $20,275 versus the small business rate of $7,705.