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FDA releases updated medical device user fee rates for FY 2027

A photo of the lawn sign for the Food and Drug Administration in in White Oak, Maryland.
Photo: Sarah Silbiger/Getty Images

Kevin Kinsella

2 min read
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FDA sets FY 2027 medical device user fees, updating submission and registration costs under MDUFA V and outlining small business reductions.

The Food and Drug Administration (FDA) has issued its annual update to medical‑device user fees for Fiscal Year 2027, covering the period from October 1, 2026, through September 30, 2027.

According to a notice appearing in the Federal Register, FDA begins its calculation with the statutory base fee for a premarket application and

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