Most FDA User Fees Will Increase By Almost 4% Next Fiscal Year
US FDA has released its 2019 device user-fee schedule, setting inflation-adjusted rates based on the MDUFA IV framework. Most applications regardless of company size will see a 3.9% increase. That's a far cry from the 32% user-fee increase for most application types in fiscal year 2018.
You may also be interested in...
Most categories of medical device user fee applications will be 6% more expensive starting in October. Establishment registration fees will see more than a 7% increase as well, regardless of whether a company is considered a small business.
Fixing Reimbursement ‘Valley Of Death’ And Repealing The Device Tax Are Top MDMA Priorities, CEO Leahey Says
In an interview about medical device lobbying priorities, the Medical Device Manufacturers Association CEO Mark Leahey talked about efforts to figure out administrative and potentially legislative solutions to gain reimbursement for products sooner after FDA approval. Leahey also argues industry groups are in a better position to permanently repeal the 2.3% medical device excise tax despite previous failures to do so.
The standard US FDA fee for a 510(k) submission will increase 124% in FY 2018, but small companies will see a much more moderate 12% jump. Other fees will increase by between 30%-40% in the coming fiscal year. And, perhaps, the biggest change will be for de novo submissions, which will have a user fee for the first time. FDA issued its inflation-adjusted user-fee schedule following the recent enactment of MDUFA IV.