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# Multi-Component Preemption Based on Each Component: Court
- URL: https://www.fdaweb.com/multi-component-preemption-based-on-each-component-court/
- Published: 2018-03-07T12:00:00.000Z
- Updated: 2026-09-14T23:28:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140928

The 3rd Circuit Court of Appeals has issued the first appellate decision that preemption for multi-component medical devices should be addressed on a component-by-component basis. Attorney **Michelle Yeary** (Dechert) says the ruling came in an appeal from a Pennsylvania federal court decision in a case involving a Smith & Nephew hip replacement multi-component device.

Yeary says the question of how to apply PMA-preemption to a multi-component device is important because surgeons engaging in off-label use mix and match parts with different regulatory backgrounds.

The 3rd Circuit found that the plaintiff’s negligence, strict liability, and breach of implied warranty claims were all preempted under the Supreme Court’s *Riegel* decision. The plaintiff argued that a preemption determination should be made by looking at the device that was implanted as a whole. But the company said the proper focus would be to look at the device component with which the plaintiff took issue.

The court found that the Federal Food, Drug, and Cosmetic Act defines “device” to include components, parts, and accessories. It also found that the law’s off-label provisions specifically acknowledge that a physician can and will use components separately from the system for which FDA approved use. The court also acknowledged that FDA says that a device is not limited to the device as a whole, but includes its components. And the agency is charged with assuring the safety and effectiveness of components as well as finished devices, the court said.