FDA last week announced a new webpage setting out its current Small Business Program. This program provides fee breaks for small businesses seeking FDA regulatory approvals.
Specifically: small business get substantially reduced fees for: Premarket Notification (510(k), De Novo request, Premarket Approval Application [PMA], Biologics License Application [BLA], Product Development Protocol [PDP]), Premarket Report (PMR), PMA/BLA Supplements and PMA Annual Reports, and 513(g) request for classification information.
This year has seen some substantial increases in FDA user fees. But the good news is that the small business exemptions have grown too. The fee breaks are substantial – often much less than half. See table below.
FDA FY 18 User Fees (in U.S. Dollars)
|Application Type||Standard Fee||Small Business Fee|
|De Novo classification||$93,229||$23,307|
|PMA, PDP, PMR, BLA||$310,764||$77,691|
|BLA efficacy supplement||$310,764||$77,691|
|PMA annual report||$10,877||$2,719|
To qualify – a small business must file tax records to demonstrate that it has revenues from sales or other receipts (including receipts from affiliate companies) below $100 million US in the last financial year. For US companies, a US tax return must be filed with FDA.
Small(er) business get a first PMA free
Businesses with gross receipts below US $30 million get an additional break, qualifying for a complete waiver of the fees for their first PMA. Given the current fee is now almost $311,000 that’s a substantial freebie.
Non US companies can apply too
Non US companies can also qualify. To do so the foreign company must obtain a declaration from their national tax authority confirming that the business meets the $100 million revenue threshold.
Take a look – if applying for US regulatory approval, it’s worth the effort to seek out the fee waivers.
Need help with US FDA filings? Brandwood Biomedical is experienced in preparing and filing US FDA submissions, including pre-submission consultations. If you are seeking US market entry and need to know more, contact us on email@example.com or call our office on +61 2 9906 2984.