Fifth round of medtech user fee talks set to begin soon

Every five years, the FDA, the medtech industry and the public sit down and hammer out how the agency should spend the money it collects in fees from medical device developers seeking approvals and clearances.

The agency also uses the Medical Device User Fee Amendment (MDUFA) to set fees for biologics license applications, 513(g) requests for information and de novo requests.

Negotiations on MDUFA V were scheduled for April 2020 but were waylayed by the pandemic. Following an initial stakeholder meeting in October, the FDA now says the virtual monthly meetings may begin in March. Congress must pass by MDUFA V by September 2022, when the current user fee law expires.

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