The FDA has released the user fee schedule for fiscal year 2023 per the terms of the new user fee agreement, and device manufacturers will see considerably higher fee amounts. One example is that the rates for PMA filings have risen to $441,547, up significantly from the $374,858 charged by the agency in fiscal 2022.
The FDA and the medical device industry struggled to come to terms on the fifth medical device user fee agreement, known as MDUFA V, and Congress needed until Sept. 30 to pass the related legislation. MDUFA V was expected to represent a substantial increase in total user fee amounts over the previous agreement, and that expectation is reflected in the new rates across the board.
Most of these rates are adjusted for small businesses, defined as entities grossing less than $100 million, which will be required to pay $110,387 for PMA filings rather than the almost $442,000 for larger companies. Companies that have receipts of less than $30 million can apply for a waiver of their first PMA fee under MDUVA V, a waiver that was also available under MDUFA IV. Following are other fees for fiscal 2023 (the device manufacturing facility registration fee of $6,493 is the same for all manufacturers in fiscal 2023).\
De novo petitions
510(k) applications
By far, the most common premarket application type for the FDA is the 510(k) application, which is applicable to medium-risk, class II devices. Some of the goals for review of 510(k) applications remain as they were under MDUFA IV, with FDA substantive interactions with the sponsor required by 60 days for at least 95% of all 510(k)s. That 95% rate for providing a substantive interaction within 60 days is identical across all five years of MDUFA V.
Similarly, the FDA is expected to return a decision on 95% of applications within 90 FDA review days in each of the five years of this agreement. For any applications that are not fully reviewed within 100 days, the agency will provide written communication to the applicant, which will be used in meetings or teleconferences to review the application.
The average total time to a decision on a 510(k) application (which includes interactions with the sponsor in addition to the 90 FDA days) is set to 128 calendar days in fiscal year 2023, falling to 124 days in the following fiscal year. The average total time to a decision is set at 112 days in the last three fiscal years of MDUFA V, although the number of days in fiscal years 2026 and 2027 may be adjusted to account for the meeting of certain performance goals.
These average total time to decision diverges significantly from the objectives set forth for MDUFA IV, which called for a decision to be rendered by 108 days in fiscal year 2022, the lowest of the five years for MDUFA IV. In fiscal 2018, the target total time for 510(k)s was 128 days.
The MDUFA V agreement calls on the agency and the applicant to achieve a shared outcome average total time to decision of 290 calendar days for PMA originals and panel-track supplements in fiscal years 2023 and 2024. However, that number of elapsed days is scheduled to fall to 285 days in fiscal years 2025-2027.
For de novo petitions, MDUFA V requires that the agency respond within 150 days for at least 70% of these filings in fiscal years 2023-2025. The benchmark for fiscal 2026 is a 150-day response for 80% of de novo petitions if the FDA reaches the 70% set point in 2023, but the success rate for fiscal year 2027 is somewhat more complicated. The agency would have to meet a 150-day turn-around time for 90% of de novos in fiscal 2027 if these reviews are returned on time in both fiscal years 2023 and 2024, but only 80% of de novos would have to be reviewed in 150 days if the agency meets the 70%/150-day goal for 2023, but misses the 70%/150-day goal for 2024.