alexa Regulatory hurdles in bringing an in vitro diagnostic device to market.
Business & Management

Business & Management

Journal of Entrepreneurship & Organization Management

Author(s): Smith KM, Kates JA

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Abstract 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.
This article was published in Clin Chem and referenced in Journal of Entrepreneurship & Organization Management

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