| Regulatory hurdles in bringing an in vitro diagnostic device to market. | |
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MedLine Citation:
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PMID: 8787729 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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We discuss the hurdles that developers and manufacturers of in vitro diagnostic devices face in obtaining regulatory approval to market their products in the US. A thorough understanding of medical device regulation and the early planning of a clinical and regulatory strategy are imperative in assuring successful and timely launches of new products. Finally, it is critical for manufacturers to establish a working partnership with the Food and Drug Administration to expedite their new product applications. |
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Authors:
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K M Smith; J A Kates |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Clinical chemistry Volume: 42 ISSN: 0009-9147 ISO Abbreviation: Clin. Chem. Publication Date: 1996 Sep |
Date Detail:
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Created Date: 1996-10-22 Completed Date: 1996-10-22 Revised Date: 2000-12-18 |
Medline Journal Info:
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Nlm Unique ID: 9421549 Medline TA: Clin Chem Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 1556-7 Citation Subset: IM |
Affiliation:
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Hybritech Inc., San Diego, CA 92196-9006, USA. KMS@Lilly.com |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Consumer Product Safety Equipment and Supplies* / standards Reagent Kits, Diagnostic United States United States Food and Drug Administration* |
| Chemical | |
Reg. No./Substance:
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0/Reagent Kits, Diagnostic |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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