FDA Lays Out Guidance on MDUFA User Fees

The FDA released a spate of new or revised user fee guidance to coincide with the Oct. 1 effective date of MDUFA IV.

The agency revised its April 2013 guidance on user fees and refunds for 510(k) submissions, including frequently asked questions, such as “Are all 510(k)s subject to user fees?” The answer is no.

What if the FDA said a device was eligible for third-party review and the 510(k) was reviewed by a third party, but the agency later determined that the device is not eligible for review by the third party? In such cases, the applicant would not have to pay a user fee. But if a 510(k) was reviewed by a third party and the device was never deemed eligible for third-party review, the applicant would have to pay a user fee, the agency said.

Applicants have to pay a user fee for a submission if they previously received a Not Substantially Equivalent determination for the device, if the submission type is subject to fees.

The agency considers a 510(k) submission withdrawn if the applicant fails to supply an electronic copy. In such cases, the FDA will return the fee.