Ingrid Mezo

The Food & Drug Administration’s user fee program collects payments from medical device makers when they submit their devices for review by the federal watchdog agency. Yesterday, MassDevice took a look at competing claims from the medical device industry, the FDA and other stakeholders over the effectiveness of the program. Today we look deeper into whether the program is adequately meeting its own goals.

Another commitment the FDA made in exchange for receiving user fees from industry was to expedite its production of guidance documents to provide industry with a "roadmap" of how to bring a product from development to clearance for sale.

It takes 20 percent longer to obtain a final decision on a 510(k) submission than it did in 2002, despite the millions the Food & Drug Administration has collected from medical device makers in so-called "user fees," according to AdvaMed’s Janet Trunzo.

Trunzo, AdvaMed’s executive vice president for technology and regulatory affairs, was one of several industry association speakers who expressed disappointment in the medical device user fee program at a Sept. 14 workshop held to gain stakeholder input on the program.

"Our companies are concerned that the link between performance and fees has broken down," said Medical Imaging and Technology Alliance executive director David Fisher.