FDA FY 2015 User Fee Rates

FDA issued the user fee rates for FY 2015, which apply from October 1, 2014, through September 30, 2015. To avoid delay in the review of your application, you should pay the standard fee before or at the time you submit your application to FDA. Table 5 of the Federal register notice contains the fees and is at the link provided.
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 (PMA, PDP, or BLA) 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 hreshold.

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

Email training@softwarecpr.com for more info.

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