| Auditing device clinical studies for US requirements. | |
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MedLine Citation:
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PMID: 18078178 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Medical device manufacturers conducting clinical studies outside the United States (US) to support US regulatory submissions should be prepared to show that these studies are conducted in a manner that will be acceptable to the Food and Drug Administration. This article discusses the audits that can be conducted to assess this acceptability. |
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Authors:
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Maria Donawa |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Medical device technology Volume: 18 ISSN: 1048-6690 ISO Abbreviation: Med Device Technol Publication Date: 2007 Oct |
Date Detail:
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Created Date: 2007-12-14 Completed Date: 2008-01-08 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9215490 Medline TA: Med Device Technol Country: England |
Other Details:
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Languages: eng Pagination: 24-7 Citation Subset: T |
Affiliation:
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Dona Consulting, Rome, Italy. medonawa@donawa.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Clinical Trials as Topic
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legislation & jurisprudence*,
standards* Device Approval / legislation & jurisprudence*, standards* Guideline Adherence / legislation & jurisprudence*, standards Medical Audit / legislation & jurisprudence*, standards United States |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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