Regulatory hurdles in bringing an in vitro diagnostic device to market

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.