Devicemakers Will Pay More for Classification Requests

Classification information devicemakers request through a 513(g) will cost 8.5 percent more this fall, and there won’t be any refunds. The 513(g) user fee, set by the Medical Device User Fee and Modernization Act, will jump to $3,191 in fiscal 2011, which begins in October. The fee for small businesses will increase to $1,595. The current 513(g) user fee is $2,941 for large companies and $1,470 for small businesses. Comments on the user fees and a draft guidance on submitting 513(g) requests are due by July 28.
Devices & Diagnostics Letter