Healthcare, Industry News, Medical Devices, Regulatory Affairs

USFDA updates on hike in user fees for the 2020 fiscal year

US Food and Drug Administration medical device have increased the user fees by about six percent for 510(k) premarket notifications, Premarket Approvals (PMAs) and other market registration applications for the 2020 fiscal year.

FDA’s user fee schedule for 2020 shall take effect from October 1, 2019, and entails six-percent increases for both standard and small-business rates. The agency’s 2020 fiscal year increases are slightly higher compared to four-percent increases for 2019 for most user fees.

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