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One thing that makes Product Liability Laws unique is the state-to-state variability that is often involved. In other words, states may not only have very different product liability laws, but even similar laws shared by states can be interpreted differently from state to state. However, when it comes to class III medical devices, Congress has made it clear by passing the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act statute that Federal Laws will trump all state Product Lability laws.
The Medical Device Amendments gave the Food and Drug Administration (FDA) the authority to conduct a cost-benefit analysis, regulate and provide detailed oversight of class III medical devices. Class III medical devices are those that are considered important to supporting or sustaining human life. This process requires a medical device manufacturer to submit an application that includes complete reports of all research and investigations of the medical device’s safety and performance. In all, the FDA spends approximately 1,200 hours reviewing each application and will only grant premarket approval if it finds “reasonable assurance” of the device’s safety and effectiveness.
Congress has determined that any medical device that has received premarket approval should not be exposed to additional or contrasting state law stipulations and is protected by express pre-emption. After a manufacturer has received premarket approval, the manufacturer is not supposed to make any changes to design specs, manufacturing procedures, labeling or any other characteristic that would influence safety or performance without FDA permission.
It is important to point out that federal pre-emption does not apply to all medical devices; it only applies to class III devices that have received premarket approval.
Another important point about federal pre-emption for class III medical devices is implied pre-emption. Implied pre-emption simply means that all business of enforcing the Food, Drug and Cosmetic Act shall be the sole responsibility of the FDA, and specifically prohibits private litigants to file suit for non-compliance with the medical device provisions.
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