President Trump has signed into law the reauthorization of the Medical Device User Fee Act (MDUFA IV)—a move that entities like the Medical Imaging & Technology Alliance (MITA) have applauded. Others, however, remain concerned about the legislation’s implications for HTM professionals.
To Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare, however, the reauthorization of MDUFA IV is a big win for the industry. “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,” Robinson says.
The legislation, approved by the U.S. Senate in a 94-1 vote after passing in the U.S. House of Representatives, builds on the 2012 user fee agreement to expedite the U.S. FDA’s device review process. To MITA officials, the legislatory changes will “enhance the predictability, consistency, transparency, and timeliness of the premarket FDA review process.”
Moreover, MITA officials say that the legislation will spur more innovation by clarifying the FDA’s authority to consider and clear new indications for imaging device manufacturers. 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—a stipulation that has been met with mixed reviews.
So, what do you think about the reauthorization of MDUFA IV? Share your thoughts below.
