OPINION OF THE COURT
GARTH, Circuit Judge:
This appeal requires that we determine how the Medical Devices Amendments of 1976, which amended the Food, Drug and Cosmetic Act of 1938, 21 U.S.C. § 360-360rr, allocates authority between the states and the Food and Drug Administration. To be precise, we must decide whether 21 U.S.C. § 360k pre-empts Nina Michael's state law causes of action for negligent manufacture and design, strict product liability...
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