- Standards & Trade >
- WTO TBT Inquiry Point >
- U.S. Notifications >
U.S. Notifications
United States of America (USA/673: Medical device labelling)
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 labelling, 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. Effective date: 30 January 2012
No Final Comment Date Given
(Texts provided by the World Trade Organization.)
updates delivered to your desktop
We have provided a link to this site because it has information that may be of interest to our users. NIST does not necessarily endorse the views expressed or the facts presented on this site. Further, NIST does not endorse any commercial products that may be advertised or available on this site.