The FDA provides the medical device user fee information, including fee rates and payment procedures, for Fiscal Year (FY) 2013 that runs from Oct. 1, 2012, through Sept. 30, 2013.


Federal law (The Food and Drug Administration Safety and Innovation Act – FDASIA) authorizes the FDA to collect user fees for certain medical device applications (see: pdf/BILLS-112s3187enr.pdf). These user fee requirements, which will be in effect for five years beginning on Oct. 1, 2012, are described in the Medical Device User Fee Amendments of 2012 (MDUFA III), which starts in Section 201 of FDASIA.


The FDA announced the FY 2013 user fees in a July 31 Federal Register notice, which can be found at: FR-2012-07-31/pdf/2012-18647.pdf.


Posted on the FDA website on 17 August 2012