Food and Drug Administration officials have proposed a revised Medical Device User Fee and Modernization Actor MDUFMA II that would raise $287 million over five years compared with the $150 million it expects to collect under the current MDUFMA program set to expire Sept. 30.
The additional funding would allow the FDA to expedite medical-device approvals and hire additional staff to manage an increasing number of device manufacturer applications, said Daniel Schultz, director of the FDAs Center for Devices and Radiological Health.
Changes include setting prescribed fees so manufacturers will have more predictable rates from year to year; assessing an FDA-registration fee on medical-device manufacturers; collecting annual report-filing fees for high-risk devices; and lowering fees charged to businesses with less than $100 million in annual revenue.
The updated act would also allow more companies to use private-sector auditors for routine inspections and shorten the application approval period for most devices. Following months of negotiations with the FDA, a spokesperson for the medical-technology trade association AdvaMed called the agreement favorable for both the agency and manufacturers.
The FDA will accept public comment on the proposal for 30 days. The FDA will present its MDUFMA II proposal in an April 30 meeting at 5630 Fishers Lane, Room 1066, Rockville, Md. -- by Shawn Rhea