Speaking Of Medtech, Ep. 5: MDUFA V User-Fee Negotiations
In this episode of Speaking Of Medtech we discuss the Medical Device User Fee Amendments, or MDUFA, the negotiations for which come around every five years. The MDUFA V talks between industry and the US FDA appear with the inevitability of an unloved season – it seems no one is ever terribly excited to engage in the user-fee process. Here, we break things down.
You may also be interested in...
Consultant (and former FDAer) Steve Silverman is back with a reflection on his predictions for 2023, and well as what he expects to see in the coming year.
Investments in medtech firms have been drying up, with some speculating the reason lies in the degree of regulatory uncertainty inherent to the field. In this opinion piece, consultant and former FDAer Steve Silverman describes how device companies can help investors clarify the risk.
In this op/ed, consultant and former FDA official Steve Silverman reveals how medical device firms can best interact with the US Food and Drug Administration's Center for Devices and Radiological Health as the COVID-19 pandemic recedes.