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The release of the FY 2018 FDA user fee schedule was delayed until the end of August, because the re-authorization of user fees was not approved until August 18, 2017. For PMA submissions and related supplements there is a 33% increase. For 510(k) submissions, the standard fee increased by 125%, while the small business fee increased by only 13%. De Novo applications will now have a large fee associated with them as well. Even the establishment licenses increased by 37%.
If you want to learn more abou the FY 2018 user fees and the strategic implications, the following blog article was posted yesterday:
Applying for small business qualification is best approach to reduce you costs of FDA regulatory submissions. If you have not completed a small business qualification form before, you can learn how to prepare your application for small business qualification by registering for a webinar this Friday, September 8, 2017:
FDA User Fee Increase for FY 2018 – Strategic Implications
This article identifies strategic implications of the FDA user fee increase for FY 2018 that was published by the FDA last week.
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