Wire · regulatory
Tarver: CDRH on a 'recruiting tear,' looking ahead to MDUFA VI
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Fusion42 · 22 October 2026 · Fusion42 review
The FDA's Center for Devices and Radiological Health (CDRH) has significantly ramped up hiring to recover from past staff losses and is preparing for the upcoming Medical Device User Fee Amendments (MDUFA VI) program covering FY 2028-2032, aimed at improving device review processes and international harmonization.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
You face faster and more transparent FDA medical device reviews soon as the center rebuilds its team and smooths processes under MDUFA VI. Plan for deeper engagement with FDA timelines and leverage improved pre-submission options to speed approvals.
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1 source · 21 Oct 2026
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