FDA requests an additional $500M in user fees from industry to add staff and expand capabilities

The FDA's device arm is hoping to secure an additional $500 million in user fees over 5 years via the reauthorization of the fourth Medical Device User Fee Act. The agency proposed adding 20 employees to establish a quality management team, about 50 to review regulatory submissions and 15 to evaluate postmarket data. But first it needs to get the backing of the industry, which will foot the bill for the increased efforts via additional user fees. More