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This past Monday, the FDA announced fiscal year (FY) 2022 medical device user fees. This upcoming fiscal year raised the user fee by 2.5% for a premarket approval application, which is 4.5% less than that was instituted last year.

Starting October 1, 2021, the base fee of $329,000 will be implemented for a premarket application received by the FDA. The standard fee for a premarket application, which includes a biologics license application, premarket report, and a BLA efficacy supplement, is about $374,858.

The total amount of revenue amount for FY 22 is near 213.7 million, which helps the FDA meet its revenue target. To help the FDA determine the next fiscal year’s fee, the agency sets the fee rate for each type of submission based on a percentage of the standard fee for a premarket application.

The Medical Device User Fee Amendments, or MDUFA, allows the FDA the authority to collect user fees from the industry for medical device submissions to help support the agency’s review activities. MDUFA provides the inflation adjustment to be compounded for FY 22, which utilizes the same methodology as that for the total revenue inflation adjustment.

Under MDUFA, the medical technology industry provides a little bit under one billion dollars to the FDA over a five-year period. In return, the MDUFA agency is responsible for meeting performance goals that improve the predictability, transparency, and efficiency of the review process. The process improvements include significantly improved review times for 510(k) and PMA submissions.

Are you struggling to get your medication or drug FDA approved? Give EMMA International a call today at 248-997-4497 or email info@emmainternational.com to learn which regulatory pathway is right for your product. We specialize in full-circle consulting to help get your product approved and out to market in the best way possible.

[1] Slabodkin, G. (2021, August 2). FDA ups premarket application user fees by 2.5% for FY 2022. MedTech Dive. https://www.medtechdive.com/news/fda-ups-premarket-application-user-fees-by-25-for-fy-2022/604279/

Abby McVay

Abby McVay

Research Analyst- Ms. McVay is EMMA International’s Research Analyst. She has experience in technical writing and clinical trials in many life science industries. She has experience with many different elements of quality and regulatory compliance. Ms. McVay holds a Bachelor of Science in Psychology from Manchester University as well as a Master of Science in Industrial and Organizational Psychology from Angelo State University.

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