Overview of MDUFMA I and MDUFA II
Like MDUFMA I, the goal of MDUFA II is intended to position FDA to better serve the public health by providing additional funds to FDA for “the process for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met.” The additional funding provided by MDUFA II will be used to promote the following significant public health benefits:
- Safe and effective medical devices will reach patients more rapidly.
- Manufacturers will receive timely, high quality reviews with greater consistency.
Next page: MDUFMA I (FY 2003 through FY 2007)