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Third-Party Oversight Of Device Changes Urged In Formal Complaint

This article was originally published in The Gray Sheet

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Executive Summary

FDA should amend its policy on device modifications to require their review by an independent third party, or the agency itself, prior to marketing, according to a Jan. 14 formal complaint

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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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