FDA: Request Small Business Status Before Sending FY 2017 Applications

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. — April Hollis