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FDA announces new device user fees with significant increases for some submissions

29 August 2017

Medical Device Alert
On August 29, 2017, FDA published a Federal Register notice with the device user fees for the Agency’s Fiscal Year (FY) 2018, which begins on October 1, 2017. Due to statutory increases, inflation adjustments and target revenue adjustments, many of the new user fees are notably higher than in the 2017 FY.

In addition, among the user fees announced for the coming year are significant new user fees for de novo requests, which have historically not had associated user fees. At the same time, the percentage discount received by small businesses (i.e., those with less than $100 million in annual revenue) has increased for 510(k) premarket notifications and is now applicable to the newly initiated de novo request fees, leading to a greater benefit for small business designation than in years past. Companies considering submissions over the next year will want to time them carefully and consider applying for small business designation as soon as possible, if applicable.

Read the full article here.


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