Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions
Information
Type
Rule
Regulated products
Medical Devices
Published
December 30, 2011
Last updated
December 30, 2011
Description
Document number 2011-33588. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)