AdvaMed Applauds House Committee Passage of Medical Device User Fee Bill
by Barbara Kram, Editor | June 25, 2007
House's approval
will improve
patients' lives
will improve
patients' lives
WASHINGTON, D.C. -- AdvaMed President and CEO Stephen J. Ubl issued the following statement after the House Energy and Commerce Health Committee night passed legislation to reauthorize the Medical Device User Fee and Modernization Act (MDUFMA), among other device-related provisions:
"AdvaMed commends the committee for its bipartisan approval of legislation that will enhance patient safety by providing FDA's device center with the necessary financial resources for the timely and effective review of new medical technologies.
"We are especially pleased that the committee removed a proposal to limit the preemptive effect of FDA's device-specific actions, which potentially would have created hundreds of standards for medical technology manufacturers. AdvaMed would particularly like to thank Committee Chairman John Dingell (D-MI) and Ranking Member Joe Barton (R-TX) for their leadership in preserving the carefully negotiated FDA/industry user fee agreement in this critical package of legislation.
"AdvaMed also praises the committee for passing the amendment offered by Reps. Jay Inslee (D-WA) and Joe Pitts (R-PA) to improve FDA's third-party inspection program. These improvements will streamline the currently burdensome procedural requirements in the third-party inspection program.
"AdvaMed encourages the full House to act promptly and join the Senate in passing legislation that maintains the agreement negotiated by FDA and the medical technology industry before the current user fee program expires on September 30."
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org
The legislation passed the committee on June 21, 2007.
"AdvaMed commends the committee for its bipartisan approval of legislation that will enhance patient safety by providing FDA's device center with the necessary financial resources for the timely and effective review of new medical technologies.
"We are especially pleased that the committee removed a proposal to limit the preemptive effect of FDA's device-specific actions, which potentially would have created hundreds of standards for medical technology manufacturers. AdvaMed would particularly like to thank Committee Chairman John Dingell (D-MI) and Ranking Member Joe Barton (R-TX) for their leadership in preserving the carefully negotiated FDA/industry user fee agreement in this critical package of legislation.
"AdvaMed also praises the committee for passing the amendment offered by Reps. Jay Inslee (D-WA) and Joe Pitts (R-PA) to improve FDA's third-party inspection program. These improvements will streamline the currently burdensome procedural requirements in the third-party inspection program.
"AdvaMed encourages the full House to act promptly and join the Senate in passing legislation that maintains the agreement negotiated by FDA and the medical technology industry before the current user fee program expires on September 30."
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org
The legislation passed the committee on June 21, 2007.
