| Medical Device; exemption from premarket notification; class II devices; pharmacy compounding systems. Final rule. | |
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MedLine Citation:
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PMID: 11706859 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for pharmacy compounding systems classified within the intravascular administration set, with certain limitations. This rule will exempt from pre market notification pharmacy compounding systems classified within the intravascular administration set and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA). |
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Authors:
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 66 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2001 Mar |
Date Detail:
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Created Date: 2001-11-13 Completed Date: 2001-12-07 Revised Date: 2004-11-17 |
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: 15796-8 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* Drug Compounding / classification*, instrumentation Equipment Design Equipment Safety Humans Legislation, Drug 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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