2014, FDA Approval and FDA Compliance

A Thorny PMA Preemption Decision from Rhode Island

Drug & Device Law

MARCH 19, 2024

It involves allegations against the manufacturer and distributor of surgical clips used in tubal ligation surgery—Class III Pre-Market Approved (“PMA”) medical devices. Plaintiff had surgery in 2014 in which the clips were used. 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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