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U.S. medical device reporting: who is responsible?
1Donawa Consulting, Rome, Italy. medonawa@donawa.com
Abstract:
When various companies are involved in the manufacture and export of medical devices to the United States (U.S.), it is not always easy to understand the reporting responsibilities under the U.S. Medical Device Reporting regulation. A new rule has been published to help companies better understand the requirements. This article discusses the new rule, ways to determine responsibilities and suggestions for compliance.