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CPI SEEKS "ORIGINAL" MANUFACTURER STATUS FOR DEVICE TRACKING REQUIREMENTS

This article was originally published in The Gray Sheet

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Executive Summary

CPI SEEKS "ORIGINAL" MANUFACTURER STATUS FOR DEVICE TRACKING REQUIREMENTS in a citizen petition recently submitted to FDA. Cardiac Pacemakers, Inc. "requests that FDA approve an exemption to allow CPI to assume the device tracking responsibilities of the original manufacturers for" 18 devices which the company distributes but does not manufacture. The St. Paul, Minnesota firm also is petitioning for an exemption "from certain distributor reporting requirements."

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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