Academic journal article Boston College Law Review

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

Academic journal article Boston College Law Review

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

Article excerpt


The principal objective of the Medical Device Amendments of 1976 ("MDA") to the Federal Food, Drug, and Cosmetic Act is to maximize the safety and effectiveness of medical devices, especially as society becomes increasingly reliant on various types of medical equipment.1 The MDA categorizes medical devices into three different classes by evaluating the level of risk that each device presents and classifying them accordingly.2 Each class of devices must therefore undergo different approval processes and meet different safety and effectiveness requirements before they can be marketed to the public.3 Class I medical devices are ones that pose little risk of harm to patients and are therefore subject to minimal federal oversight.4 Class II medical devices, which have the potential to be more dangerous, must comply with additional performance standards the federal government sets forth to be marketed.5 Class III medical devices pose the greatest risk of harm to patients and therefore receive the highest level of federal oversight, which often entails individualized requirements imposed on each device that condition the device's ability to enter and remain on the market.6 The MDA also has a preemption provision that prohibits state and local governments from enacting requirements directed at the safety and effectiveness of medical devices if their requirements either differ from or add to those imposed under the MDA.7

In a case of first impression, the United States Court of Appeals for the Third Circuit, in Shuker v. Smith & Nephew, PLC (Shuker II), considered the application of the MDA to a medical device that consisted of multiple components, one of which came from a different Class III device although the rest were components of a Class II device.8 Taking into consideration the fact that a device's classification affects the application of the preemption provision, the Third Circuit had to decide whether to analyze the device at the component-level, thus focusing on the Class III component that was the source of the plaintiffs' claims, or at the device-level, therefore regarding the overall system as a Class II device.9 After considering the text and application of the MDA, as well as guidance from the Food and Drug Administration ("FDA"), the court held that the device should be analyzed at the component-level.10

This Comment argues that the Third Circuit properly analyzed the device at the component-level.11 Part I discusses the legal and factual history of Shuker II.12 Part II sets forth the arguments made by the parties in favor of either a device-level or component-level approach.13 Lastly, Part III ar- gues in favor of the court's ruling that hybrid devices should be analyzed at the component-level.14


Section A of this Part discusses the various classifications and approval processes under the MDA and the ways in which they affect a preemption analysis under the MDA.15 Section B of this Part examines the factual and procedural history of Shuker II.16

A. The Medical Device Amendments: Classifications and Preemption

The rigorous "premarket approval" process for a Class III device requires the manufacturer to submit a detailed report discussing the device's safety and efficiency to the FDA and provide it with a sample of the device and its proposed labeling, which establishes the device's conditions of use.17 The FDA spends, on average, approximately 1,200 hours reviewing these applications and, after weighing the device's possible benefits and risks, grants premarket approval only if the manufacturer has provided sufficient assurance that the device is both safe and effective.18

The FDA may impose additional requirements or restrictions on a Class III device as a condition to its approval to enter or remain on the market.19 After receiving premarket approval, the device must continue to be manufactured and marketed in a way that is entirely consistent with the requirements set forth in the FDA's premarket approval order. …

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