The Medical Imaging & Technology Alliance (MITA) provided its assessment of the Medical Device User Fee Amendments (MDUFA) IV and outlined its goals for MDUFA V in a comment letter to the U.S. FDA. Given satisfactory FDA performance under MDUFA IV, MITA does not anticipate any need for significant new commitments or funding increases in MDUFA V.
“Through the current iteration of the User Fee Program, MDUFA IV, the FDA has produced satisfactory premarket review performance results, which we hope to carry into MDUFA V,” says Patrick Hope, executive director of MITA. “The User Fee Program is working as intended, and this status quo should be maintained. It is our position that User Fees be stabilized around current funding levels, well below 50% of total program costs.”
Under MDUFA IV, the FDA launched new initiatives, pilot programs, and special projects to investigate novel digital technologies and other emerging regulatory considerations. While the value proposition of these programs remains to be seen, MITA will continue working with the FDA over the remainder of the current User Fee iteration to determine the value for premarket review of these initiatives. As the letter notes, “A key area of discussion will be whether these programs should continue to be funded by User Fees or in other ways.”
“As it enters its third decade, the User Fee program has achieved maturity, delivering consistently satisfactory results for the industry, and enabling safe and effective innovative technologies to reach patients and healthcare providers efficiently and expeditiously,” Hope adds.
The comment letter also underscored MITA support for the existing 510(k) substantial equivalence pathway and its continued utilization under MDUFA V, asserting that this premarket review pathway is a “cornerstone” of efficiently bringing safe and effective medical technologies to market.
“At the broadest level, as we enter discussions regarding the fifth iteration of MDUFA, MITA would like to carry forward what has been working and leave behind what has not. We look forward to working with the Agency and reaching an agreement that supports the ongoing efficient delivery of efficacious medical imaging devices to providers and the patients they serve,” concludes Hope.
For more information, read the full comment letter.