FDA Restricts Ovarian Adnexal Mass Assessment Score Test System with Black Box Warning

Posted 30 December 2011 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) on Friday amended regulations classifying ovarian adnexal mass assessment score tests (OAMAST) systems to include a black box warning restriction that must appear in all advertising, promotion and labeling materials.

The OAMAST system is used to assess the likelihood that an adnexal pelvic mass is malignant by measuring the presence of certain proteins in serum or plasma.  The device is not intended to be used as a screening or diagnostic tool for ovarian cancer.

The FDA determined that off-label use could lead to "a high frequency of unnecessary further testing and surgery due to false positive results, or to delay in tumor diagnosis due to false negative results."

The black box warning is aimed at combating those risks by providing clear warnings for indication for use and contraindications for use.

The black box warning falls under a Class II special control.

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