EMERGO SUMMARY OF KEY POINTS:

• FDA user fees for the 2018 fiscal year have increased across all registration categories.
• 510(k) fee paid by companies that don't qualify for small business discount will more than double.
• Annual Establishment Registration fee increasing 37% with no discount for small businesses.

US Food and Drug Administration user fees for medical device registrants will increase across the board for the agency’s next fiscal year starting October 1, 2017.

The FDA’s 2018 user fees, established by the recently enacted Medical Device User Fee Amendments of 2017 (MDUFA IV), will increase for all registration-related categories, including a sizeable fee increase for 510(k) premarket notification submissions by larger companies. Fortunately, the 510(k) submission fee for small/mid-size businesses will rise at a much lower rate. 

FDA registrants wanting to lock in 2017 fiscal year rates better hurry as the current rates expire on September 30, 2017. 

Standard FDA registration fees for larger companies increasing by 33% with the 510(k) application fee rising 125%

MFUFA IV entails substantial standard fees across all registration categories as seen in the table below. All prices below in US Dollars. 

Source: US FDA, Emergo

In addition, FDA Establishment Registration fees will jump 37% to $4,642 for the 2018 fiscal year from $3,382 in 2017. This fee is not discountable for small businesses. 

Most small business fees will see 33% increases as well...except for 510(k)

As with standard FDA user fees, some user fees for small businesses also decreased from 2016 to 2017, but will go up for 2018. Fortunately, the fee for 510(k) submission review by the FDA only went up by 13%. All prices below in US Dollars. 

Source: US FDA, Emergo

How to qualify for small-business user fees

In general, a manufacturer must have sales of $100 million or less for the most recent tax year in order to qualify for discounted small-business user fees. In addition, firms with $30 million or less in sales may also have fees for their first Premarket Application (PMA) or premarket report waived. Interested organizations should submit proof of qualification at least 60 days prior to submitting their registration applications to the FDA.

The FDA has recently published updated guidance on its small-business user fee qualification and certification process for 2018; Emergo will discuss this new guidance and what it means for small and start-up medical device companies in a separate blog post coming soon.

New fees for De Novo classification requests

For the first time, the FDA will begin assessing user fees for De Novo medical device classification requests for its 2018 fiscal year. Standard fees for such requests will be US$93,229, while small-business fees will be US$23,307. These new fees may have a significant impact for smaller manufacturers seeking to bring cutting-edge devices and technologies to market in the US; Emergo will provide additional analysis of this new fee and its effects in the near future.

Additional US FDA resources and services from Emergo:

• US FDA 510(k) consulting support for medical device companies
• FDA Establishment Registration and FURLS listing support
• Video overview: The US medical device regulatory process
• Whitepaper: Preparing an FDA 510(k) submission