The Medical Imaging & Technology Alliance (MITA) – the leading trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices – reiterated its support for the fifth iteration of the Medical Device User Fee Agreement (MDUFA) following the U.S. House of Representatives Energy and Commerce Health Subcommittee hearing to consider the U.S. Food & Drug Administration (FDA) user fee reauthorization.
Representing MITA during the hearing, Diane Wurzburger of GE Healthcare noted that, “User Fees provide for an efficient pre-market review process allowing for innovative medical devices to get to patients and healthcare providers in an expedient, consistent, and transparent manner. MITA member companies are actively developing innovative new technologies that will depend on efficient regulatory pathways to patient access. The User Fee program will enable premarket review of advanced imaging platforms.”
FDA Director for the Center for Devices and Radiological Health, Dr. Jeff Shuren, also gave testimony and answered questions from subcommittee members. In response to a question on the need for clarity around the definition of remanufacturing, Shuren noted the FDA would support such a measure.
“There is value for providing greater clarity and maybe even doing so through statute with further expansion than through guidance,” Shuren said. “When we saw reports come in, the allegations of problems with servicing, most of those turned out to be remanufacturing. So, clarity about what constitutes and what doesn’t constitute remanufacturing is critically important.” MITA supports the recently introduced H.R. 7253, The Clarifying Remanufacturing to Protect Patient Safety Act, which would do just that.
In addition to Wurzburger and Shuren, other MDUFA witnesses included Dr. Richard Kovacs representing the American College of Cardiology, Mark Leahey representing the Medical Device Manufacturers Association and Janet Trunzo from the Advanced Medical Technology Association.
MITA Urges Swift Passage of MDUFA V Agreement