FDA Releases Guidelines for Small Businesses on MDUFA Fees

The FDA issued guidance for small businesses seeking a discount on medical device application user fees or a waiver for a first premarket application fee and began accepting small business certification requests for fiscal 2019 on Aug. 1.

The agency is raising its standard fee for pre-market applications, product development protocols or biologics license applications to $322,147, up from $310,764 for fiscal 2018. But qualified small businesses will pay much less for the applications, as well as premarket reports and efficacy supplements: $80,537 for each. Small-business 510(k) premarket notification submissions will cost $2,738 and de novo classification requests will cost $24,161.

To qualify for the lower fees, a business must have gross receipts or sales of no more than $100 million for the most recent tax year. That includes the gross receipts of any affiliates, including parent companies or subsidiaries. The fiscal year 2019 user fees go into effect on Oct. 1.