The Medical Imaging & Technology Alliance (MITA) has applauded the U.S. Senate’s passage of the reauthorization of the Medical Device User Fee Act (MDUFA IV). MITA officials say this legislation builds on the 2012 user fee agreement to improve the U.S. FDA’s device review process while maintaining high standards for patient safety.
“The Senate passage of MDUFA is another critical step toward a victory for patients, the industry, and the agency,” says Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare. “As the bill moves to the White House for signature, we applaud the bipartisan efforts of the House and Senate to find reasonable, common-sense solutions to clear regulatory hurdles that hinder medical innovation and ensure patient access to life-saving technology.”
According to MITA, 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.
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, the FDA only regulates medical device service activities performed by a manufacturer.
Legislators also commented on the U.S. Senate’s passage of the reauthorization of MDUFA IV. In a statement, Energy and Commerce Committee Chairman Greg Walden (R-Ore.), Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-N.J.), Health Subcommittee Chairman Michael C. Burgess, MD, (R-Texas), and Health Subcommittee Ranking Member Gene Green (D-Texas) said: “Working together, House and Senate Republicans and Democrats brought forth a bill to reauthorize these important programs, putting patients first and their hope for new treatments within reach.”
“This bill is a win for patients and the millions of Americans working to develop our next generation of cures and therapies,” they added. “We applaud the Senate’s swift action in passing this vital bill, and urge President Trump to sign it into law.”
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