Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
AdvaMed investigates "device lag": AdvaMed is studying the phenomenon of "device lag", whereby new medical technologies are often first available outside of the United States, and has engaged consulting firm PricewaterhouseCoopers to do a comprehensive review of the issue, AdvaMed CEO Stephen Ubl announced during a Feb. 24 media briefing on policy priorities. New devices are commonly available first in Europe, Ubl noted, "and surely we should be asking the question whether that is appropriate and whether we can do a better job with respect to some technologies making sure they're available in the U.S. first." The review, which is due in May, will examine "certain data elements" in nine countries, including regulatory review timelines and investment levels, "to try to get a better handle on whether this device lag occurs and [identify] potential solutions," Ubl said. "Candidly, the interest is in stimulating a race to the top, to be able to visit with ... government leaders across markets [with] a valid, objective measurement of how well various components of their system are doing in the service of patient access to medical technology." The study comes as FDA evaluates potential changes to its 510(k) program with an eye toward improving device safety, which could slow market access (1"The Gray Sheet" Feb. 22, 2010)