Devicemakers seeking small business status for fiscal year 2017 should apply before submitting any product applications, a new FDA guidance advises.
Businesses with gross receipts or sales of $100 million or less for the most recent tax year qualify for a “significant reduction” in user fees, the FDA said. Those with $30 million or less qualify for a one-time waiver of the fee for their first-ever PMA application, BLA application, product development protocol or premarket report.
For fiscal 2017, the Premarket Application (PMA, BLA, PDP) fee for standard businesses is $234,495 while small businesses pay $58,624. The establishment registration fee remains the same for both small businesses and standard businesses ().
Requests for small business status for fiscal 2017 must be submitted by Sept. 30. If the status is granted, it will expire Sept. 30, 2017. Devicemakers should submit a new MDUFA Small Business Qualification and Certification each year to qualify as a small business, the guidance advises.
For both U.S.-based and foreign applicants, the FDA will review the application and supporting documents within 60 days. If a business qualifies, the FDA’s decision letter will assign a Small Business Decision number that should be provided anytime a discount or waiver is sought.
U.S. businesses applying for small business status should submit:
Foreign businesses should take several steps in the following order:
Companies with foreign affiliates should submit a separate certified Section III of Form FDA 3602A for each foreign affiliate. If the company has U.S. affiliates, it should send a U.S. federal income tax return for each of them.
The guidance is available at www.fdanews.com/08-04-16-smallbusiness.pdf. — April Hollis