Devices

Support for MDUFA 4

Four healthcare organizations are voicing their support for provisions of the MDUFA 4 reauthorization for 2018-2022. The American College of Cardiology says it was interested in three goals in the MDUFA 4 negotiations — a stable, predictable approval pathway; utilization of stakeholder experience; and development of a medical device evaluation system. “It is clear from the draft agreement as well as the stakeholder agreement process that these concerns were heard and considered,” the comment letter says.

The California Life Sciences Association (CLSA) says that overall, MDUFA 3 was a positive step forward for patients, industry, and FDA in laying the groundwork for a significantly improved regulatory environment. “There is still work to be done to ensure that rigorous science and safety standards can coexist alongside predictable and efficient review processes,” the association says. It describes the MDUFA 4 agreement as “a necessary measure in strengthening the regulation of medical devices while continuing to promote patient health through the timely approval of and access to innovative technologies. “In particular,” it says, “CLSA supports that MDUFA 4 emphasizes the importance of patient engagement and involvement in the medical device review process by focusing on voluntary patient preference information and voluntary patient report outcomes. In addition, the agreement puts important process improvements in place and ensures greater stakeholder accountability through the establishment of a quality system management approach to the device review process. Lastly, the agreement also supports a pilot program to assess the use of real-world evidence to support premarket activities.”

In its letter, Johnson & Johnson associates itself with positive comments made by AdvaMed and says the reauthorization “will support critical improvements in resources and policies that will accelerate the review process and should shorten the time it takes to move products from research bench to the patient’s bedside. At the same time, we believe these improvements will improve patient safety by providing more rapid access to life-saving devices.”

Finally, FasterCures, a Milken Institute center, says the recommendations in the FDA MDUFA 4 commitment letter “will continue to enhance and improve the device review program as a whole.” FasterCures particularly supported agreements on patient engagement and the science of patient input, scientific and regulatory review capacity, and real-world evidence.

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