Document Detail


Regulatory hurdles in bringing an in vitro diagnostic device to market.
MedLine Citation:
PMID:  8787729     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
K M Smith; J A Kates
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Clinical chemistry     Volume:  42     ISSN:  0009-9147     ISO Abbreviation:  Clin. Chem.     Publication Date:  1996 Sep 
Date Detail:
Created Date:  1996-10-22     Completed Date:  1996-10-22     Revised Date:  2000-12-18    
Medline Journal Info:
Nlm Unique ID:  9421549     Medline TA:  Clin Chem     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1556-7     Citation Subset:  IM    
Affiliation:
Hybritech Inc., San Diego, CA 92196-9006, USA. KMS@Lilly.com
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MeSH Terms
Descriptor/Qualifier:
Consumer Product Safety
Equipment and Supplies* / standards
Reagent Kits, Diagnostic
United States
United States Food and Drug Administration*
Chemical
Reg. No./Substance:
0/Reagent Kits, Diagnostic

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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