Under the Medical Device User Fee & Modernization Act, FDA collects user fees from manufacturers seeking approval to market devices. In return for the user fees, which supplement Congressional appropriations, FDA is expected to meet certain performance goals to improve the timeliness of its premarket reviews. MDUFMA sunsets Sept. 30, requiring reauthorization of the program. FDA's proposal for reauthorization includes the following provisions, in summary:
Collectively, the device industry would pay 31% more in user fees in fiscal 2008 than in fiscal 2007 to meet increased FDA costs. The fees would increase 8.5% annually over the next five years.
Individual application fees would decline significantly beginning in FY 2008 as the overall financial burden is spread more broadly through the introduction of two new annual fees - one for establishment registration ($1,700) and one for filing periodic reports ($6,500). The new fees are geared to account for 50% of all device user fees, and would create a more consistent revenue stream for the agency.
Small businesses would get a bigger break as application fees are further reduced from current levels for firms with annual sales of $100 million or less.
FDA's interim review "cycle" goals would be eliminated, enabling the agency to refocus on an interactive review process, while some of its final approval decision goals are made more rigorous.
Proposal includes provisions for diagnostic imaging and IVD guidances, as well as for streamlining and expanding the "accredited person" third party inspection program.
Current MDUFMA "triggers" tied to device-specific appropriations and agency spending would be extended intact.
This article is reprinted from "The Gray Sheet" – April 23, 2007
“The Gray Sheet” – Comprehensive news and analysis for medical device professionals. Click here for a free, 30-day trial.
© FDC Reports 2007 - All Rights Reserved