Device Week, 18 June 2021 – MDUFA V Update; FDA’s Shuren Speaks; Harmonized QS Reg Almost Here?

Device Week, 18 June 2021 – MDUFA V Update; FDA’s Shuren Speaks; Harmonized QS Reg Almost Here?

Pharma Intelligence

On this week’s podcast we give an update on the Medical Device User Fee Amendments (MDUFA V) process. We also discuss US FDA device center director Jeff Shuren’s comments about pre-submission meetings and IVD submissions…

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