title: 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.
authors.affiliation: Hybritech Inc., San Diego, CA 92196-9006, USA. KMS@Lilly.com
authors.forename: K M
authors.initials: KM
authors.lastname: Smith
authors.forename: J A
authors.initials: JA
authors.lastname: Kates
mesh_terms: D003257:Consumer Product Safety; D004864:Equipment and Supplies / Q000592:standards; D011933:Reagent Kits, Diagnostic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011933:Reagent Kits, Diagnostic