Industry trade group Medical Imaging and Technology Alliance (MITA) has issued a statement praising U.S. policymakers' continued attention to the issue of medical device user fee payment and thanked the Senate Committee on Health, Education, Labor, and Pensions for holding a hearing on the topic on July 28.
MITA is participating in ongoing negotiations with the Food and Drug Administration (FDA) to reauthorize the Medical Device User Fee and Modernization Act and is seeking improved FDA performance in that effort, the alliance said.
In a statement, David Fisher, MITA executive director, said that the alliance shared the committee members' concerns at the July 28 hearing that the FDA device review performance has deteriorated, leading to longer overall review times and less timely access to medical innovations. MITA is committed to continued collaboration with regulators, industry partners, and other stakeholders to achieve the goal of a stable, clear, and timely medical device clearance process, he said.