Regulatory Issues in the Development and Marketing of Lateral Flow Immunoassays

  • Raphael C. WongEmail author


As with all other medical devices, commercializing a lateral flow immunoassay device requires special attention to regulatory issues. Negligence may prevent the device from being marketed no matter how good the product is. This chapter will address some of these regulatory issues as encountered in the United States and the rest of the world. A flow chart of the pertinent processes is presented in Fig. 11.1. Since regulations are constantly being updated, the issues discussed only reflect the common practices at the time of publication of this book. It is prudent that a device developer should have adequate resources in both regulatory and legal arenas to address these issues and to do it vigilantly.


European Union Patent Office Provisional Application Certification Body Clinical Laboratory Improvement Amendment 
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Copyright information

© Humana Press, a part of Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Branan Medical CorporationIrvineUSA

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