User Fees a Test of New Administration for Device Companies

User Fees a Test of New Administration for Device Companies

MDUFAs, fees paid for the inspection agencies to review medical device applications, will be a top priority for device makers with a new administration in the White House.  The medical device industry advocates for legislation on a bipartisan basis, and medical device issues enjoy more bipartisan support than most industries. This is because of their geographically diverse base and supportive senators from both parties. That being said, it is logical for medtech to expect a sympathetic hearing from the incoming administration, especially as they opposed President Obama’s signature healthcare reform legislation.

Kalorama Information covers the global device market in our report on the topic - The Global Market for Medical Devices.

Still, it is too early if the abstract political change of the election will lead to concrete action. One test of the new admin’s stance towards the device industry will be the Medical Device User Fee Agreement fee negotiations. It cost over $200,000 for a standard business to launch a new device with the FDA and $4,700 for a “shortcut” or 510 (k) application off a previously approved device. There are also inspection fees for facilities that manufacture some devices.

The fees are justified as a way to enable the FDA to staff appropriately to make approval decisions in a helpful timeframe.  These fees are substantially reduced for a small business. Fees were down over ten percent from 2016. A further reduction or limited/no increase are goals of the industry.

Likewise, improving the FDA regulatory process, and an outright repeal versus suspension of the medical device tax are other trends the industry will be advocating for. While the industry through its lobby group AvaMed will seek ACA repeal, they also signaled they’d like to see coverage of newly insured not disrupted, as they said “ensuring that the coverage process allows patient access to the latest innovations.”