Medical Device User Fee Stabilization Act of 2005

MEDICAL DEVICE USER FEE STABILIZATION ACT OF 2005 -- (House of Representatives - July 26, 2005)

BREAK IN TRANSCRIPT

Mr. DEAL of Georgia. Mr. Speaker, I thank the gentlewoman from California for yielding.

In 2002, Congress passed the Medical Device User Fee and Modernization Act, and it allowed the Food and Drug Administration to collect user fees from manufacturers who would submit applications for medical devices. This legislation was in response to the fact that there were many applications for new devices, and we were falling behind in the approval process.

With the passage of this legislation, the FDA was authorized to add additional personnel, and have done so and have speeded up the approval time for these new devices.

However, the legislation provided that Congress had to set and reach certain marks of appropriations for fiscal year 2003 and through 2005 for this program to continue; and in the event we did not reach those targeted appropriation levels, then the program would expire at the end of this September. Unfortunately, Congress did not meet those targeted appropriation levels.

Since Congress did not reach the targeted appropriations required to keep the program in place, this user fee program will cease at the end of September, and the FDA will be required to start sending out notices of termination.

So this legislation is essential to keep this very successful program in place, and it will allow us to retain the medical personnel who are working and approving device applications in a much more speedy and rapid fashion than they would have been able to do without the user fee being in place.

Mr. Speaker, that is the purpose of this legislation is to extend the program.

BREAK IN TRANSCRIPT

http://thomas.loc.gov