Advertising and Promotion of In Vitro Diagnostic Products

Posted 01 May 2011 | By Seth Mailhot, JD 

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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