EMERGO SUMMARY OF KEY POINTS:

• The US FDA has a new guidance out that includes a FAQ on MDUFA IV user fees and refund policies for de novo medical device premarket submissions.
• Only de novo devices intended for pediatric applications and those submitted by government entities and not intended for commercialization will be exempt from user fees.
• Because new user fees are substantial, de novo device applicants should carefully consider FDA policies described in the guidance.

US medical device regulators at the Food and Drug Administration have published new guidance explaining new user fee and related requirements for de novo device classification requests that took effect October 1, 2017.

The new FDA guidance includes several Frequently Asked Questions (FAQ) covering which types of de novo classification requests require applicants to pay user fees as mandated by the Medical Device User Fee Amendments of 2017 (MDUFA IV), exceptions to de novo request user fee requirements, and which FDA actions may result in user fee refunds for de novo request applicants.

De novo user fees for the FDA’s 2018 fiscal year are $93,229 (standard fee) and $23,307 (small business fee); given these substantial costs, de novo applicants should carefully consider agency policies for fee payments and refunds, and how those policies may impact their US commercialization efforts. As Emergo previously reported, new de novo user fees may present a significant obstacle to US market entry for some device manufacturers.

(FDA has also recently issued a separate guidance on regulatory performance goals for de novo classification requests.)

Which de novo requests require user fee payment?

FDA makes only two exceptions in terms of types of de novo classification requests that do not incur user fees under MDUFA IV: Submissions for devices intended only for pediatric patient populations, and submissions from state or federal government entities that do not intend to commercialize their devices.

In addition, applicants do not have to pay user fees if responding to an FDA request for additional information regarding a de novo request already submitted to the agency.

How user fee refunds are handled for FDA de novo requests

FDA will issue refunds for de novo user fee payments for applicants that mistakenly paid fees for devices that are intended solely for pediatric applications, or for applicants that are government entities and do not plan to commercially distribute their devices after regulatory review.

Once a de novo applicant pays its user fee and submits a validated eCopy of that payment to FDA, that applicant’s de novo request is considered officially accepted for review and ineligible for a refund. FDA will also not issue refunds in cases where de novo requests are accepted for review and then declined.

However, applicants whose de novo requests are considered withdrawn because they fail to provide eCopies of their user fee payments within official timeframes will qualify for refunds.

FDA recommends consulting with agency personnel prior to submitting a de novo request to help determine whether the medical device in question is appropriate for the de novo marketing authorization route.  

Resubmitted de novo applications subject to additional user fees

According to the guidance, de novo applicants whose submissions are declined by FDA reviewers will have to pay additional user fees if they decide to resubmit their devices for registration.

Resubmissions will be subject to user fees according to applicants’ new chosen market pathway; new de novo requests will be subject to de novo user fees, while 510(k), Premarket Approval (PMA) and other premarket submissions will incur their respective user fees.

Additional US medical device regulatory information:

• US FDA medical device classification consulting
• US FDA submission support for medical devices and IVDs
• Whitepaper: FDA regulations for novel and innovative devices
• Whitepaper: The FDA medical device classification system
• In-depth video: The US FDA medical device registration process