That covers a good deal of the industry already. Humanitarian devices could be exempt, too. Deconstructing this last clause, it's conceivable that if a dominant device manufacturer or group of manufacturers simply refused to market new devices, FDA would have no recourse but to waive the fees, which would probably bring about a domino reaction in the industry. But, from a practical standpoint, that seems extremely unlikely. On the other hand, although it may seem fair from a humanitarian perspective to waive fees for smaller companies, it hardly seems fair or tenable from a Constitutional viewpoint.
Challenges are inevitable.
In the meantime, manufacturers looking to express their opposition to device user fees can start by visiting MDMA' s user fee opposition page , which gives the names of Congressional committee members along with a sample letter of complaint and an industry-wide petition. In other news.