Narrowing in on the Problem: A Component-Level Analysis of "Hybrid" Medical Devices

Abstract

The Medical Device Amendments of 1976 (“MDA”) classify medical devices into three categories, each of which represents a different level of risk, and requires a different level of federal oversight. Class III devices, which pose the most risk, are subject to the highest level of oversight. Those devices are protected from any claims based on state laws that differ from or add to the requirements imposed by the MDA. On March 1, 2018, the United States Court of Appeals for the Third Circuit, in Shuker v. Smith & Nephew, PLC, considered the application of preemption under the MDA to a “hybrid” device, which was made up of various Class II components and one Class III device. The Third Circuit held that these devices are to be considered at the component level, thus allowing hybrid devices with Class III components to be protected from state-law claims. This Comment argues that the Third Circuit’s level of analysis, which looked at the requirements imposed on the specific component at issue rather than the device itself, was the proper method of evaluation.