EMERGO SUMMARY OF KEY POINTS:

• New FDA user fees for de novo medical device registrations may impact some manufacturers’ plans for commercialization of novel and cutting-edge products in the US.
• Even small-business FDA user fees for de novo applications may prove too high for some prospective US medical device market registrants.

News that the US Food and Drug Administration will begin charging user fees for de novo medical device registration applications for the agency’s 2018 fiscal year may cause some cutting-edge device manufactures to think twice about pursuing US marketing authorization.

According to the Medical Device User Fee Act of 2017 (MDUFA IV), the FDA’s 2018 user fees include a standard fee of $93,229 and a small-business fee of $23,307 for de novo submissions. While de novo device manufacturers and developers may likely qualify for small-business user fees if their annual sales total less than $100 million, a $23,000 entry fee will still seem very steep for some of these firms.

Prohibitive cost of US market entry?

How could new and substantial user fees for de novo device registrations affect manufacturers seeking a foothold in the world’s largest medical device market for novel, cutting-edge products?

Stuart Goldman, Senior Consultant, QA/RA at Emergo, observes that although it is not surprising that the FDA would begin charging for de novo registrations given the amount of time and resources involved in these reviews, the amount of the new user fees likely caught many industry participants off guard.

“While most companies that need to go the de novo route with FDA are likely going to be eligible for the small-business user fee, that is still a very high fee,” says Goldman, adding that for some companies the new fee may prove prohibitive enough that they’ll decide to commercialize their devices in other markets with lower premarket registration costs.

US medical device regulators have demonstrated intentions to ease some premarket authorization requirements for novel and cutting-edge technologies; the FDA’s Digital Health Innovation Action Plan and Early Feasibility Study (EFS) program provide two recent examples. But the agency’s new user fees for de novo devices also create a potential new hurdle for some of these manufacturers and developers.

Related US medical device market resources from Emergo:

• US FDA consulting for medical device and IVD companies
• Regulatory consulting support for telehealth and mobile medical app developers
• Whitepaper: FDA regulations for novel and innovative devices