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.