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A Thorny PMA Preemption Decision from Rhode Island

Drug & Device Law

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 did not allege that the design of the clips deviated from the FDA approved design. Coopersurgical, Inc. 2024 WL 1109055 (D.R.I. 14, 2024).

FDA 52