Advertising and Promotion of In Vitro Diagnostic Products

| 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.

 

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