FDA Hikes Premarket Application User Fees by 2.5 Percent

Applying for FDA premarket review of medical devices will be more expensive next year. On Aug. 2, the agency announced that it’s raising premarket approval (PMA) user fees by 2.5 percent in FY 2022.

PMA User Fees

The FDA sets the fee rate for each type of submission based on a specified percentage of the standard fee for a premarket application. The Medical Device User Fee Amendments of 2017 (MDUFA IV) gives FDA the authority to collect user fees from the industry for certain medical device submissions to help pay for the agency’s review activities. The MDUFA IV requires the FDA to meet performance goals designed to improve the efficiency, speed and transparency of the PMA and 510(k) review process. In return, the medtech industry provides the FDA $999.5 million in additional financial resources over a five-year period.

In FY 2022, the $329,000 base fee and $4,978 establishment registration fee will be adjusted “using the same methodology as that for the total revenue inflation adjustment,” according to the agency. The good news is that the resulting 2.5 percent adjustment for the year, which takes effect on Oct. 1, 2021, will be considerably less than the 7 percent increase in the user fee that the agency implemented in FY 2021.