The Food and Drug Administration (FDA) officially kicked off the process of reauthorizing the Medical Device User Fee Amendments (MDUFA) for fiscal years 2018 through 2022 today with a public hearing at FDA's White Oak Campus in Silver Spring, MD. MDMA's President and CEO Mark Leahey participated in the meeting along with other representatives from industry, FDA, the public and more.
MDMA's comments focused on providing background information on the evolution of MDUFA, noting a significant increase in fees over the years, and that the goal for MDUFA IV should be on making FDA more efficient and consistent through process enhancements, not simply making the Agency larger. To view background information on the meeting, which includes an archived link to the webcast, please click here. To view the Federal Register Announcement, please click here.