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Clinical Chemistry 42: 1556-1557, 1996;
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Clinical Chemistry, Vol 42, 1556-1557, Copyright © 1996 by American Association for Clinical Chemistry

Regulatory hurdles in bringing an in vitro diagnostic device to market

KM Smith and JA Kates
Hybritech Inc., San Diego, CA 92196-9006, USA. KMS@Lilly.com

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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Copyright © 1996 by the American Association for Clinical Chemistry.