MDMA Seeks FDA Commitment to Modify User Fee Review Program

FDA's Center for Devices and Radiological Health (CDRH) and its Center for Biologics Evaluation and Research (CBER) held their First Annual Stakeholders Meeting relating to the implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). MDMA Executive Director, Mark Leahey, participated on panels discussing how the user fee process is working one year into the program; electronic labeling and Section 301; bundling, modular PMA and expedited applications; third party inspections; and reuse. Paul Touhey, MDMA's immediate past chairman and president of Fujirebio Diagnostics, Inc., also presented at the meeting.