| Medical devices; exemption from premarket notification requirements; class I devices; technical amendment. Final rule; technical amendment. | |
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MedLine Citation:
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PMID: 11725800 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is amending the language in its medical device classification regulations for class I devices for consistency, to include in sections where it was not present, a specific reference to the limitations on exemptions from premarket notification requirements for each generic device classified. The specific reference language was included when some class I generic devices were first exempted under provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). These amendments will provide the same reference for devices that were exempted before that time. The language is intended to conveniently provide the reference, and make the sections clear and easy to read. The status of the devices is not being changed. |
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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 Jul |
Date Detail:
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Created Date: 2001-11-28 Completed Date: 2001-12-07 Revised Date: 2009-11-03 |
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: 38786-819 Citation Subset: T |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Device Approval
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legislation & jurisprudence* Equipment and Supplies / classification* Humans Legislation, Medical 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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