Washington, D.C. – Today the Medical Imaging & Technology Alliance (MITA) applauded the U.S. House of Representatives for its passage of the reauthorization of the Medical Device User Fee Act (MDUFA IV). This legislation builds on the progress from the 2012 user fee agreement to further improve the U.S. Food and Drug Administration’s (FDA) device review process while maintaining its robust standards for patient safety.

“MITA is encouraged by the reauthorization of MDUFA by the House and sees the user fee agreement as a win for patients, the industry and the agency,” said Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare. “We are hopeful that the momentum of this legislation in Congress will take it over the finish line in the Senate and that it will be signed into law in short order.”

The legislation clarifies the FDA’s authority to continue to consider and clear new indications for imaging device manufacturers, while providing contrast agent manufacturers with incentives to update contrast agent labels for products that have previously been approved, which will help spur cutting-edge innovation for patients.
The legislation also calls for the FDA to produce a report on the quality and safety of devices with respect to servicing within 270 days of enactment. Currently, only medical device service activities performed by a manufacturer are regulated by the FDA. If a device fails to perform in a safe and effective manner due to improper servicing by an unregulated, third-party organization, it could potentially put the patient at risk for serious physical injury or result in low image quality – which could lead to a delayed or missed diagnosis.

“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,” said Robinson. “MITA and its members believe that all MDUFA commitments should be backed by appropriate, measurable and predictable performance goals that support these principles.”

MDUFA IV, negotiated between the 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 & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment 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 www.medicalimaging.org. Follow MITA on Twitter @MITAToday.

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