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"Pre-market approval" of a medical device by the FDA imposes specific requirements and triggers the pre-emption provisions of the Medical Device Amendments of 1976, a federal judge in Pennsylvania has ruled. The judge found that since the U.S. Supreme Court's leading case on MDA pre-emption -- the 1996 decision in Medtronic Inc. v. Lohr -- federal and state courts have held that the approval process causes pre-emption of many state-law claims.
February 11, 2004 at 12:00 AM
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The original version of this story was published on Law.Com
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