US industry hears legal view on, GPOs (group purchasing organisations) gain-sharing revival
This article was originally published in Clinica
Executive Summary
In the device world, products that are substantially equivalent to a predicate device can be cleared for marketing under a 510(k). Now, ensuring product equivalence is becoming a key issue in another arena with the growing interest in gain-sharing arrangements, where hospitals reward their doctors for employing cost-saving steps, such as switching to lower-cost devices.