Compliance, FDA Approval and FDA Compliance

A Thorny PMA Preemption Decision from Rhode Island

Drug & Device Law

MARCH 19, 2024

Plaintiff did not allege that the design of the clips deviated from the FDA approved design. Nor did plaintiff allege that the clips were manufactured in a way not approved by the FDA. The court answered that question affirmatively for plaintiff’s design defect and manufacturing defect claims.

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A Thorny PMA Preemption Decision from Rhode Island

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