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Regulatory News | 28 July 2016 | By Zachary Brennan
Medical device companies will see a modest decrease in application fees for FY 2017 when compared to 2016, according to new fee rates released Thursday by the US Food and Drug Administration (FDA).
The 2017 standard fee for a premarket application, premarket report and efficacy supplement (in effect from 1 October 2016 to 30 September 2017) will be $234,495, which is $26,893 less than FY 2016’s fees.
Panel-track supplement fees, however, will reach their lowest point ever – at $175,871 – which is more than $20,000 less than last year’s fee. That kind of reduction is similar to reductions offered under the 2017 rates for the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA)released Wednesday, and the Generic Drug User Fee Act (GDUFA)fees unveiled on Tuesday.
The other fees include:
What’s unique about the Medical Device User Fee Act (MDUFA) is that if a company has gross receipts or sales of no more than $100 million for the most recent tax year, it can qualify for reduced small business fees.
And if a device company has gross sales or receipts of no more than $30 million, it may also qualify for a waiver of the fee for the first premarket application, product development protocol, biologics license application or premarket report.
“You must include the gross receipts or sales of all of your affiliates along with your own gross receipts or sales when determining whether you meet the $100 million or $30 million threshold,” FDA says. “If you want to pay the small business fee rate for a submission, or you want to receive a waiver of the fee for your first premarket application or premarket report, you should submit the materials showing you qualify as a small business 60 days before you send your submission to FDA.”
However, FDA notes that if companies want to pay a reduced small business fee, they must qualify as a small business before making a submission to FDA; and if they do not qualify as a small business before making a submission, they will have to pay the higher standard fee.
FDA also notes that if the establishment registration fee is the only medical device user fee that a company will pay in 2017, it should not submit a FY 2017 Small Business Qualification and Certification request.
Medical Device User Fee Rates for Fiscal Year 2017
Tags: MDUFA, medical device user fees