MITA Applauds Signing of MDUFA IV into Law

08.18.17

Washington, DC – The Medical Imaging & Technology Alliance (MITA) today applauded President Trump for signing into law 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 vigorous standards for patient safety.

“We commend the President and the bipartisan efforts of Congress to enact MDUFA IV, which will improve the transparency and efficiency of the FDA review process for the benefit of patients,” said Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare. “The passing of this legislation is the result of a concerted effort by MITA and its industry partners who worked closely with the FDA and Congress. We are confident that this legislation will be a critical component in ensuring that all patients have timely access to life-saving medical technologies.”

The law, approved by the U.S. Senate in a 94-1 vote, which previously passed the House of Representatives, includes several process improvements that will enhance the predictability, consistency, transparency and timeliness of the premarket FDA review process. The legislation clarifies the FDA’s authority to consider and clear new indications for imaging device manufacturers, which will help spur more innovation. It 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.

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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.