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Medtech Firms To See Significant User Fee Increases In FY 2020

Most categories of medical device user fee applications will be 6% more expensive starting in October. Establishment registration fees will see more than a 7% increase as well, regardless of whether a company is considered a small business.

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Most user fees will see a 6% increase starting on 20 Oct.

Medical device and diagnostics companies will see a significant increase in user fee application costs in the next fiscal year. While last year the US Food and Drug Administration raised most user fees almost 4% after adjusting for inflation, the agency has used the same formula to increase rates again but this time by 5.85%.

On 31 July, the FDA published its rates for user fees for fiscal year 2020 based on the deal...

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