Earlier this week, the federal Food and Drug Administration (FDA) issued a notice in the Federal Register (80 Fed. Reg. 46033) announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2016, which apply from October 1, 2015 through September 30, 2016. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. For FY 2016, the standard premarket application (PMA) fee will be $261,388; by comparison, the PMA fee in FY 2015 is $250,895.

Additionally, on July 13, 2015, FDA held a public meeting on the reauthorization of the medical device user fee program. The current legislative authority for the medical device user fee program expires in September 2017 and new legislation will be required for FDA to continue collecting user fees for the medical device program. Comments related to that public meeting are due August 12, 2015 and can be submitted here.