U.S. medical device reporting: who is responsible?
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.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D018795:Device Approval / Q000331:legislation & jurisprudence*; D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D007373:Interinstitutional Relations; D038622:Internationality; D019221:Mandatory Reporting; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*