The FDA issued new guidance this month detailing cases in which a medical device manufacturer may be eligible for a refund of the user fee paid for agency review.
The federal watchdog agency described user fee protocols for both 510k and premarket approval applications, laying out the general guidelines the FDA will follow in determining whether the applicant may be able to request a user fee refund.
The new guidance fits with the FDA’s new Medical Device User Fee & Modernization Act, which Congress authorized in June 2012 to bump up the user fees that medical device makers pay for agency review. The agency has since issued new guidances on 510(k) time-frames, PMA approval time lines, 510(k) pre-review sessions and more in efforts to streamline and clarify the medical device review pathway.
A pair of guidances issued this week aim to make clear the user fee exception and refund eligibility for various types of 510(k) and PMA applications.
In general, both types of review are eligible for the same types of exemptions – user fees need not be paid on medical device applications intended solely for a pediatric population or if the application is filed by a state or federal entity on a device that is not intended for commercial distribution.
Sponsors may be further exempt from 510(k) user fees if the application is considered eligible and undergoes review by an FDA-accredited 3rd party prior to submission to the FDA, and there is a 1-time PMA fee waiver for qualifying small businesses submitting their 1st application. PMA submissions for biologics intended solely for manufacturing use are also exempt from user fees, according to the PMA guidance.
The new PMA and 510(k) guidelines also share certain refund eligibility protocols, such as those for early application withdrawal. Sponsors can request a refund of an entire 510(k) user fee or 75% of a PMA application if the FDA hasn’t worked on it. If a 510(k) application has already been accepted for review, no refund will be issued for a withdrawal.
If the FDA has begun work on a PMA application, the agency may refund the user fee as long as the FDA hasn’t taken "1st action." The FDA defined 1st action as something akin to an approvable or non-approvable letter, and any refunds requested after that action has been taken would take into account the effort the FDA has already spent on the application, based generally on the number of days the application has been under review.
For both types of applications, the FDA will refund any user fees if the application is not accompanied by an acceptable electronic copy, which is now required of all medical device review applications. If none is provided or the eCopy filed is not up to the agency’s technical standards, the FDA will notify the sponsor and keep the application on file for 180 days to allow for a new submission. After that point the agency will delete the application from its system and refund the user fee.
The FDA also agreed to refund any users fees paid on an incomplete PMA or 510(k) application. The agency will conduct an initial review of each 510(k) or PMA application and determine whether the information provided is sufficient for review. If the application is incomplete, the sponsor can choose to withdraw the submission and request a refund of the user fees paid.
The PMA rules trickle down further for each type of PMA application, including 180-day supplements, panel-track supplements and 30-day notices. Read through the exception and refund criteria for each PMA type here, or for 510(k) submissions here.