FDA, FDA Approval and FDA Compliance

A Thorny PMA Preemption Decision from Rhode Island

Drug & Device Law

MARCH 19, 2024

Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements. Plaintiff did not allege that the design of the clips deviated from the FDA approved design.

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A Thorny PMA Preemption Decision from Rhode Island

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