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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;
- 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.
