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.

The fiscal year 2019 user fees, which devicemakers pay when they register their establishments and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S., and for certain other types of submissions for, go into effect on Oct. 1.

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.

Business can qualify for a “first premarket application/report” fee waiver if they (and their affiliates) have gross receipts or sales of $30 million or less, so long as the FDA determines that the neither the organization nor its affiliates have previously submitted a premarket application/report—whether or not it was approved.

Organizations that have applied in the past will find the process “substantially similar” to the FY 2018 guidance. But the FDA says it “continues to make quality improvements in the program, in areas such as administrative completeness and consistency of documentation,” in order to help applicants develop and submit their certification requests and for the FDA to review the requests in “a consistent, timely manner.”

The FDA says it will review application forms and supporting materials within 60 days, then will notify businesses whether or not they qualify. Status as a small business begins on the date of FDA’s decision letter and expires at the end of the fiscal year. Companies must submit new requests and supporting documents annually.

If a business submits an application before going through the small-business certification process, it will have to pay the standard fees; there are no refunds. Businesses that hope to qualify as small businesses should not submit an application that requires a fee until they have a ruling from the FDA and a small business decision number.

The final day to submit an application is Sept. 30, 2019.

The guidance also includes instructions for foreign businesses and U.S. businesses with foreign affiliates as well as step-by-step directions for filling out the relevant FDA forms.

Read the full guidance here: www.fdanews.com/08-02-18-UserFee.pdf. — Gienna Shaw