AdvaMed Commends Full House Passage of MDUFA V Agreement
WASHINGTON, D.C. – Scott Whitaker, president and CEO of AdvaMed, the world’s largest trade association representing medical technology companies, released the following statement on House of Representatives passage (392-28) last night of the “Food and Drug Amendments of 2022” legislation including the Medical Device User Fee Amendments (MDUFA). The content reflects an historic agreement, known as MDUFA V, between the industry and the Food and Drug Administration. The full House vote follows unanimous bipartisan (55-0) approval by the House Committee on Energy and Commerce last month. The Senate Health, Education, Labor and Pensions Committee is working on its own version of the legislation, also containing the core agreement.
“We appreciate the bipartisan work of the House of Representatives in advancing this important reauthorization. Medical technology developers and manufacturers depend on timely FDA consideration of devices to serve patients. The MDUFA V agreement includes firsts for greater accountability, predictability, consistency, and communication to increase patient access to safe, effective medical innovations. The House vote advances improvements to a critical system serving patients with ever-emerging medical advancements for better diagnosis, relief, and treatment.”
# # #
About AdvaMed 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. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.