“We Need to Rethink the Whole Thing”: Jeff Shuren Will Aim High on MDUFA V-Linked Reforms

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ARTICLE SUMMARY:

The next user fee negotiation process, MDUFA V, kicks off next year, and it should be interesting. FDA device center director Jeff Shuren is signaling plans to seek big-ticket legislative reforms that he hopes will give his center more leeway to implement new regulatory frameworks, and to more fully engage in a global pre-market review program.

FDA doesn’t want to be timid in the next round of device user fee negotiations. That was made clear by device center director Jeff Shuren in the closing moments of The MedTech Conference, where he urged a packed room in Boston to “really think about, where do we want to be as an ecosystem” over the long term, in advance of the MDUFAV user fee reauthorization process that will kick off next year to reach final legislation before the current program expires in 2022.

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