AdvaMed Welcomes FDA User Fee Legislative Package
WASHINGTON – Following the release of the House Energy and Commerce Committee’s FDA User Fees Legislative Package, the Advanced Medical Technology Association (AdvaMed) released this statement from President and CEO Scott Whitaker:
“As AdvaMed continues to study the specifics of this reauthorization legislation, we want to extend our sincere appreciation to Chairman Pallone and Ranking Member McMorris Rodgers and to the lawmakers on the House Energy and Commerce Committee who have crafted a bipartisan package that prioritizes patient health and safety. I am pleased to see the core elements of the MDFUA reauthorization are what we have been advocating for over the course of the negotiations, such as improved performance metrics, pre-submission guidance for companies, and new policies on use of carry-over balances.
“We stand at the edge of a Golden Age of medical technology and innovation, and as we look to the future of what our industry is capable of achieving, I am confident that the resources made available to FDA in this legislation can get us there. AdvaMed stands ready to continue working with Congressional leaders and the Administration to embrace innovation in the medtech industry and improve care for patients.“
Earlier this year, AdvaMed testified before Congress on the reauthorization of MDUFA V. During her testimony, AdvaMed’s Janet Trunzo said, “We approached this reauthorization with the same two overarching principles we have had in the past: Patients must continue to benefit from access to safe and effective devices; and the user fee program and its associated goals should be refined and improved. We also recognized that the COVID-19 public health emergency had required a significant effort by FDA, and in particular by the Device Center, given the hundreds of Emergency Use Authorizations submitted and issued for diagnostic tests, ventilators, and personal protective equipment, and other devices that were critical to the nation’s response to COVID-19.”