The Medical Imaging & Technology Alliance (MITA) – the leading trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices – applauded the passage of S.4348, The Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA) by the Senate Health, Education, Labor and Pensions (HELP) Committee. Specifically, the bill includes provisions related to Food and Drug Administration (FDA) medical device user fees and advances user fee reauthorization.
“We appreciate the leadership of Chairman Murray and Ranking Member Burr to move this legislation and medical device user fee reauthorization forward,” said Patrick Hope, MITA’s executive director. “This measure reflects the ongoing collaboration amongst FDA, device stakeholders and members of Congress to deliver an agreement that will best serve American patients. While there is still work to be done to reconcile outstanding concerns on cybersecurity provisions, unregulated device remanufacturing, and ensuring medical imaging agents continue to be classified and regulated as drugs, we are optimistic that, working together, these issues can be addressed.”
FDASLA will now be referred to the full Senate for consideration. Another version of the user fee package legislation, The Food and Drug Amendments of 2022 (H.R. 7667), passed in the House of Representatives on June 8.
“MITA is eager to continue working with policymakers to reach a final reauthorization of medical device user fees that enables an effective, well-resourced FDA capable of fulfilling its mission to protect and promote the public health,” Hope concluded.