SUPREME COURT REMANDS MITCHELL V. COLLAGEN PMA PREEMPTION CASE, SETTING STAGE FOR EARLY TEST OF MEDTRONIC V. LOHR'S EFFECT ON PMA DEVICES
This article was originally published in The Gray Sheet
The Supreme Court July 1 instructed a lower court to re-review Mitchell v. Collagen Corp., a case involving liability claims against a device approved through FDA's premarket approval application process. The move sets up one of the first tests of how the Court's recent ruling against 510(k) preemption in Medtronic v. Lohr will be applied by lower courts to PMA-approved products.
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