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FDA Device User Fees Climb For FY2023

 
• By Elizabeth Orr

The US Food and Drug Administration has announced higher user fees for FY2023, with most fees jumping about 18% while 510(k) fees saw an eye-popping 56% increase.

3D illustration of a dial with dollar symbol with needle pointing the red zone.
• Source: Shutterstock

The US Food and Drug Administration has released its medical device user fees for FY2023, which began on 1 October. The new fees are the first to be set under the Medical Device User Fees Amendment (MDUFA) V, which President Biden signed into law late last week.

The fee for a standard PMA will be $441,547, up $66,689 from last year’s $374,858. That’s a 17.79% jump, about...

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