Small FDA User Fee Discount on the Horizon for Medical Device Companies

The U.S. Food & Drug Administration is set to drop user fees for medical device companies by approximately 7% in 2012. This announcement came earlier this month straight from FDA. Though the thought of FDA decreasing fees out of sheer generosity in such difficult economic times, this is not really the case. This small but seemingly nice gesture is actually a simple return of excess funds that medical device company users already paid. FDA is required to return any industry funds that exceed the fee amount enacted by Congress for the first four years of the Medical Device User Fee Amendments of 2007 (MDUFA II). Documents released by the agency (which can be seen here) outline the adjusted fees for the 2012 year. The annual user fee for medical device companies will decrease from $2,179 in 2011 to $2,029 in 2012. Other reductions in the prices for 510(k) and general premarket submissions are listed as well. Of the expected $18 million that will exceed the $61.86 million appropriated to the agency by MDUFMA II, about $8.5 million is classified as unearned revenue which leaves $9.5 million that the agency plans to give back to the industry. On the surface the discount appears as a deal for medical device company users, but it comes as a simple return of only a small portion of the excess fees previously paid by users.

To see a full account of the agency’s plan, see the August 1, 2011 MedCity News article here.