FDA User Fees Rise for 2020

FDA user fees are going up overall by about 6% for the next year. But there’s good news. Fees are only going up 2.7% for premarket applications (PMAs).

On July 31, 2019, the agency announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2020. The new fees apply from October 1, 2019, through September 30, 2020.

How much will companies be nicked by these increases? FDA estimates $200 million for FY 2020 (October budget year).

Here’s a link to the fees schedule on the Federal Register.

Here’s the updated price list for major approval and clearance categories.

• Premarket applications (PMA): $340,995, or $85,249 if you qualify as a small business
• 510(k) premarket notification submission: $11,594, or $2,899 for small business
• De novo classification request: $102,299 or $25,575 for small business

Small Business Qualification

You qualify as a small business if your business, including your affiliates, has gross receipts or sales of no more than $100 million for the most recent tax year. If your business, including your affiliates, has gross sales or receipts of no more than $30 million, you may also qualify for a waiver of the fee for your first premarket application (i.e., PMA, PDP, or BLA) or premarket report.

Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA). User fees were renewed in 2007, in 2012, and in 2017 with the Medical Device User Fee Amendments to the FDA Reauthorization Act (MDUFA IV). MDUFA IV will be in place from Oct. 1, 2017, until Sept. 30, 2022.