Home 5 Articles 5 Agency Imposes 2.5 Percent Increase in 2022 Premarket Application User Fees

Agency Imposes 2.5 Percent Increase in 2022 Premarket Application User Fees

by | Sep 6, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

Although the FY 2022 fees increase is less than half of last year’s increase, applying to the US Food and Drug Administration (FDA) for premarket review of medical devices will still be more expensive next year. On Aug. 2, the agency announced that it is raising premarket approval (PMA) user fees by 2.5 percent in FY 2022. How PMA User Fees Work 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 medical technology 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 […]

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