| Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process. | |
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MedLine Citation:
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PMID: 21909977 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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The FDA's Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and effectiveness of all medical devices marketed within the US. To date, CDRH has cleared numerous hernia mesh devices for general use, but has not cleared/approved any mesh devices intended for certain specific uses, such as for infected wounds, hernia prevention, biofilm reduction, or prevention of adhesions. CDRH is requesting that manufacturers seeking specific hernia mesh device labeling claims consult with the Agency to determine the level of evidence necessary for justifying such claims. |
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Authors:
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B S Ashar; J M Dang; D Krause; M C Luke |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-9-11 |
Journal Detail:
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Title: Hernia : the journal of hernias and abdominal wall surgery Volume: - ISSN: 1248-9204 ISO Abbreviation: - Publication Date: 2011 Sep |
Date Detail:
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Created Date: 2011-9-12 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9715168 Medline TA: Hernia Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Office of Device Evaluation, Center for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue, WO 66, Room 422, Silver Spring, MD, 20850, USA, Binita.Ashar@fda.hhs.gov. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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