DTCI: ‘Justification to file’ on medical device review

A medical device which “presents a potential unreasonable risk of illness or injury” that cannot be alleviated by alternate means such as proper labeling, prohibitions against adulteration, performance standards, or post-market surveillance falls within Class III under the Medical Device Amendments to the Food, Drug and Cosmetic Act.

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DTCI: The broad scope of MDA preemption

In a series of decisions culminating in Riegel v. Medtronic, Inc.,  federal courts came to recognize that the
Medial Device Amendments preempted not only traditional products liability claims such as those based on an alleged defect
or implied warranty but also causes of action premised on theories such as consumer fraud.

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