title: Medical devices; ovarian adnexal mass assessment score test system; labeling; black box restrictions. Final rule.
abstract: The Food and Drug Administration (FDA) is amending the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document must be in a black box and must appear in all labeling, advertising, and promotional material. The black box warning mitigates the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery.
mesh_terms: D000291:Adnexal Diseases / Q000145:classification* / Q000175:diagnosis; D003944:Diagnostic Techniques, Obstetrical and Gynecological / Q000145:classification*; D005260:Female; D005833:Genital Neoplasms, Female / Q000145:classification* / Q000175:diagnosis; D006801:Humans; D007159:Immunologic Tests / Q000145:classification* / Q000295:instrumentation; D056687:Off-Label Use / Q000331:legislation & jurisprudence; D010051:Ovarian Neoplasms / Q000145:classification* / Q000175:diagnosis; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D012698:Serologic Tests / Q000145:classification* / Q000295:instrumentation