Regulatory


Reaching an agreement


The Medical Device User Fee Agreement was recently passed for the fifth time since its inception in 2002. However, it took months of negotiation between the FDA and multiple stakeholders to get to an agreement. Peter Weems, director of policy and strategy at Medical Imaging and Technology Alliance, explains to Peter Littlejohns what the concerns of the medical device industry were going into negotiations with the agency and whether MDUFA V has assuaged them.


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very five years since 2002, the FDA has presented an updated user fee structure to Congress for approval. It’s widely regarded as a piece of must-pass legislation because it determines the amount of revenue the FDA can collect from medical device companies, which includes manufacturers of IVDs, for its submission and review process. This time, the process was pushed to the wire, being packaged into a Continuing Resolution bill, and passed on 30 September 2022 – the day the previous MDUFA


expired. Peter Weems, director of policy and strategy at Medical Imaging and Technology Alliance (MITA), was a part of the discussions leading up to the agreement. “Negotiations unfolded over a year to a year and a half and happened under very unusual circumstances given the ongoing Covid-19 public health emergency,” he says. “During the pandemic there have been resource challenges for the FDA and as we move beyond and hopefully find ourselves at the tail end, we want to make sure the


Medical Device Developments / www.nsmedicaldevices.com


Andrey_Popov/ Shutterstock.com


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