Starting October 1, 2015, your FDA user fees are going up by 4.2%. The FDA expects to collect a total of almost $130 million from industry over the course of fiscal 2016.
FDA User Fees Rise 4.2% for 2016
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A notice by the FDA in the Federal Register on August 3, 2015 announced the fee rates and payment procedures for medical device user fees for fiscal year 2016. The rates will apply from October 1, 2015, through September 30, 2016. The 4.2% increase comes after a 2.9% fee cut in fiscal 2015. Fees climbed 4.2% in fiscal 2014.
For 510(k) clearances, the fee rises from $5, 018 to $5, 228. For premarket applications (PMAs), the fee goes from $250, 895 to $261, 385.
Small Business Break
There is a break for small businesses.
If your business has gross receipts or sales of no more than $100 million for the most recent tax year, you may qualify for reduced small business fees. If your business has gross sales or receipts of no more than $30 million, you may also qualify for a waiver of the fee for your first premarket application or premarket report.
Important Links
To pay the annual establishment fee, firms must access the Device Facility User Fee (DFUF) Web site at: https://userfees.fda.gov/OA_HTML/furls.jsp.
To read the entire Federal Registry Notice, including payment levels and procedures, click here. — WE
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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