| Medical devices; general and plastic surgery devices; classification of non-powered suction apparatus device intended for negative pressure wound therapy. Final rule. | |
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MedLine Citation:
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PMID: 21090144 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is classifying the non-powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for the guidance document entitled "Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy." |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 75 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2010 Nov |
Date Detail:
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Created Date: 2010-11-22 Completed Date: 2010-11-30 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7808722 Medline TA: Fed Regist Country: United States |
Other Details:
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Languages: eng Pagination: 70112-4 Citation Subset: T |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Device Approval
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legislation & jurisprudence Equipment Safety / classification Humans Negative-Pressure Wound Therapy / classification*, instrumentation Suction / instrumentation United States United States Food and Drug Administration |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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