Fixing a 510(K) Loophole: In Support of The Sound Devices Act of 2012

Abstract

The current medical device regulatory system contains a dangerous loophole. While the voluntary recall of a harmful medical device removes it from the market, new devices that claim they are substantially equivalent to the recalled device can still reach the market through the 510(k) premarket notification process. Devices that have gained regulatory clearance in this fashion have caused considerable harm and are much more likely to be recalled for safety reasons as well. The recently proposed Safety of Untested and New Devices Act of 2012 (the “SOUND Devices Act”) would fix this loophole. This paper describes the 510(k) clearance process and the recalled predicate loophole, summarizes the SOUND Devices Act’s proposed solution, and argues that Congress ought to enact the SOUND Devices Act.