By Stewart Eisenhart, Emergo Group
Center for Devices and Radiological Health (CDRH) director Jeffery Shuren has advocated rejection of 510(k) clearances in instances where applicants’ predicate devices have undergone safety recalls.
Shuren has argued for Congress to vest the CDRH with new authority to implement and enforce such a policy at the same time that legislators have introduced a new bill, the Safety of Untested and New Devices Act of 2012, which would do just that if passed into law.
This is hardly the first time the FDA’s substantial equivalence policy has come under fire: In 2011, the Institute of Medicine issued recommendations to abandon substantial equivalence entirely—not just in cases where predicate devices have been recalled—in favor of a more robust system to evaluate safety and effectiveness. FDA and CDRH officials did not welcome the IOM’s suggestion that the 510(k) process be scrapped outright, but these latest statements from Shuren indicate at least a willingness to acknowledge some glaring imperfections of the premarket notification policy.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.