MITA Testifies at MDUFA IV Negotiations Hearing


MITA Testifies at MDUFA IV Negotiations Hearing

MITA Calls on Congress to Swiftly Reauthorize User Fee Program

Washington, D.C. – Diane Wurzburger, Executive of Regulatory Affairs for GE Healthcare, testified on behalf of the Medical Imaging & Technology Alliance (MITA) yesterday at the Medical Device User Fee Act (MDUFA IV) negotiations hearing before the U.S. House of Representatives Committee on Energy and Commerce Subcommittee on Health, calling for swift reauthorization of the program.

“The tentative MDUFA IV agreement advances our shared goals of protecting access to safe and effective medical devices,” said Wurzburger. “If enacted, the agreement will improve FDA review of medical devices, ensuring that American patients have timely access to these technologies. MITA supports the FDA in proposing this agreement to Congress, and will continue to partner with FDA and other stakeholders in asking Congress to reauthorize this critical program.”

MDUFA IV, negotiated between FDA and the medical device industry in 2016, builds on the progress from the 2012 user fee agreement to further improve the agency’s device review process while maintaining its robust standards for patient safety. The latest agreement includes several process improvements that will enhance the predictability, consistency, transparency and timeliness of the premarket review process, including reduction in 510(k) total time to clearance; pre-submission meeting metrics; inclusion of the basis for deficiencies in all deficiency letters and appropriate supervisory review; FDA quality management program and audits; independent assessment; and additional reporting metrics. It will also establish a conformity assessment program for accredited testing laboratories that evaluate medical devices according to certain FDA-recognized standards.

The medical imaging community has long advocated for enhanced predictability, consistency, transparency and timeliness of the agency’s pre-market approval and clearance process for medical imaging technologies and other devices. MITA and its members believe that all MDUFA commitments should be backed by appropriate, measureable and predictable performance goals that support these principles.


The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment, radiation therapy and radiopharmaceutical manufacturers, innovators and product developers. It represents companies whose sales comprise more than 90 percent of the global market for advanced medical imaging technology. For more information, visit Follow MITA on Twitter @MITAToday.