Medical Device User Fees on the Rise for FY 2016

Devicemakers looking to get new products on the market should prepare to shell out more money in fiscal year 2016, as user fees for all types of applications are rising.

The new fees are as follows:

• Standard fee for PMA, $261,388;
• Panel-track supplement, $196,041;
• 180-day supplement, $39,208;
• Real-time supplement, $18,297;
• 30-day notice, $4,182;
• 510(k), $5,228;
• 513(g) request for classification information, $3,529;
• Annual periodic reporting fee for Class III device, $9,149; and
• Annual registration fee, $3,845.

Fees for 510(k)s will be $210 higher than the current fiscal year, while those for PMAs will jump $10,493. Fees for panel-track supplements also will rise sharply to $196,041 from $188,171 in FY 2015. Total revenue for FY 2016 is $129.3 million, according to an Aug.3 Federal Register notice. For FY 2015, base revenue was $125.8 million.

Small businesses — defined as enterprises with gross receipts or sales of no more $100 million for the most recent tax year — may be eligible for reduced fees. For example, qualifying businesses would pay $65,347 for their PMAs.

Those businesses with gross sales or receipts of no more than $30 million may also qualify for a waiver of the fee for the first premarket application (PMA, PDP or BLA) or premarket report.

Entities that won small business status in FY 2015 must requalify this year to maintain this designation. The notice contains instructions on how both foreign and domestic businesses may apply for this status.

The fees will apply from Oct. 1 through Sept. 30, 2016.

To read the Federal Register notice, visit www.fdanews.com/080315-user-fee.pdf. A guidance document providing additional details on user fees is available at www.fdanews.com/080215-guidance-fees.pdf. — Elizabeth Hollis