How could the Medical Device User Fee Amendment V Impact your MD company?

by: Stephen Tyrpak  – Operations MD, US & Canada; Executive Consultant @ PQE Group

In the late 1990’s and early 2000’s, the FDA began losing critical resources that were needed to facilitate timely review of medical device applications as well as to provide necessary resources to regularly update guidance documents that are essential for both FDA staff and Medical Device companies. In 2002, the medical device industry and Congress came together to develop the Medical Device User Fee and Modernization Act of 2002. The act was passed:

“in order to provide the Food and Drug Administration (FDA) with the resources necessary to better review medical devices, to enact needed regulatory reforms so that medical device manufacturers can bring their safe and effective devices to the American people at an earlier time, and to ensure that reprocessed medical devices are as safe and effective as original devices”

The act has already seen three amendments (MDUFA II, III & IV). The amendments have continued to increase the resources available to the agency while also requiring performance goals and commitments from the agency in order to receive these resources. The next amendment, MDUFA V, is currently under review and has, in my opinion, the greatest potential for supporting Medical Device Companies in the coming years. Providing support is important, but understanding how to utilize the support to its fullest is up to the Device Manufacturer.

What is in MDUFA V?

Although MDUFA V has not officially been passed yet, industry and congress have already agreed on the some of the largest aspects of the proposed amendment. The amendment would include:

  • Enhanced hiring and performance goals that, if met, would result in first-ever additional funding;
  • Clear pre-submission goals that will reduce the total time to issue FDA decisions for medical devices; and
  • New policies on carry-over balances and unused funds.

The important thing to realize is that as the Medical Device community continues to grow at an exceptionally fast rate, MDUFA V is providing the FDA what it needs to “keep up.” The ability to hire more experts who better understand the niche aspects of medical devices (like biofilms, software as a medical device, cyber security, etc.) will not only allow for quicker, more consistent review processes, but the available resources may present more guidance and support in the development and approval process. It is up to the sponsors to understand what resources are being made available and how to leverage those resources to continue down the least burdensome pathway.

Want to know more?

If you would like to learn more about MDUFA V or would like to ask our experts about their thoughts on the ever changing regulatory landscape, join our FREE Webinar on July 13 at 12:30 EST

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