Where Equivalence Isn't Equivalent: Using 510(k)s In Patent Litigation

Medical devices—encompassing everything from contact lenses to hemodialysis machines—are fundamental components of modern medicine. The regulatory bodies that govern these devices include FDA, which is charged with ensuring the safety and efficacy of the devices, and the Patent and Trademark Office (PTO), which seeks to encourage innovation by rewarding inventors with patents. While truly new devices must go through FDA's rigorous Premarket Approval (PMA) process, the majority of devices utilize the Agency's simplified Premarket Notification (PMN) process, more commonly known as the 510(k) process. To use the faster and cheaper 510(k) option, a device must be "substantially equivalent" to a previously approved "predicate device."