Advertising and Promotion of In Vitro Diagnostic Products
Posted 01 May 2011 | By
The laws and regulations governing the advertising and promotion of in vitro diagnostic (IVD) devices are complex. Various regulatory agencies and entities share overlapping authority over IVDs, and, therefore, a substantial amount of regulatory understanding is required to effectively navigate the systems. The risks of noncompliance with regulatory requirements are significant, as shown by the $262 million civil False Claims Act settlement paid by Quest Diagnostics in 2009.