Regulatory News In Brief

AdvaMed 510(k) study: Study prepared for AdvaMed by Battelle Memorial Institute finds that just 0.16% of the nearly 47,000 devices cleared via 510(k) since 1998 were involved in a Class I recall, the most serious category. The study looked at recall data from January 2005 to May 2010. Of the nearly 3,000 PMAs approved since 1998, 0.85% were subject to a Class I recall. A similar study of FDA recall data was presented by Baker & Daniels attorney Ralph Hall at a recent Institute of Medicine workshop (1"The Gray Sheet" Aug. 2, 2010). "These studies reinforce the fact that the basic structure of the 510(k) process is sound," AdvaMed CEO Stephen Ubl said in a Sept. 15 statement. The data is telling in light of FDA's "sweeping proposed reforms" to the 510(k) program, AdvaMed executive David Nexon said during a Sept. 15 call. "As we look at the [FDA] recommendations, some of them are very constructive," such as more training for reviewers and better guidance, "but some are very troublesome because they would add to the complexity and difficulty of getting products developed or approved," Nexon said