MITA Encouraged by Senate HELP Committee Hearing on User Fees


Rosslyn, Va. –  The Medical Imaging & Technology Alliance (MITA) today voiced its support of policymakers’ continued attention to the issue of medical device user fee payment and thanked the Senate Committee on Health Education, Labor & Pensions for holding a hearing on the topic this morning. MITA is participating in ongoing negotiations with the Food & Drug Administration (FDA) to reauthorize of the Medical Device User Fee and Modernization Act and is seeking improved FDA performance in that effort.

“MITA is encouraged by the attention that is being given to the reauthorization of the user fee programs. It is essential that the negotiations yield a fair agreement that all parties can support. Getting the policies right, and thereby ensuring new technologies reach patients, is the most important goal,” said David Fisher, Executive Director of MITA. “We share the concerns that were echoed by nearly every member of the Committee who attended today’s hearing that FDA device review performance has deteriorated, leading to longer overall review times and less timely access to medical innovations. A stable, clear and timely medical device clearance process is essential to protecting public health and ensuring that the latest medical imaging innovations are available to patients. MITA is committed to continued collaboration with regulators, industry partners and other stakeholders to achieve these goals.”