Regulatory hurdles in bringing an in vitro diagnostic device to market.
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.
Smith
K M
KM
Hybritech Inc., San Diego, CA 92196-9006, USA. KMS@Lilly.com
Kates
J A
JA
D003257:Consumer Product Safety; D004864:Equipment and Supplies / Q000592:standards; D011933:Reagent Kits, Diagnostic; D014481:United States; D014486:United States Food and Drug Administration
D011933:Reagent Kits, Diagnostic