The relevant passage in the Medical Device Amendments of 1976 "is not, and never was, intended to preempt all common law claims of consumers injured by a federally approved medical device."

– Senate Judiciary Committee chairman Pat Leahy (D-Vermont), commenting on the necessity of introducing the Medical Device Safety Act in the wake of a recent Supreme Court decision awarding federal preemption protection for device PMAs, "Senate adopts Pallone bill for medical device pre-emption."

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