# Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions
> **Food and Drug Administration** · Final rule. · Published 2011-12-30 · Effective 2012-01-30 · 76 FR 82129
## Document
- **Document number:** 2011-33588
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 82129
- **CFR reference:** 21 CFR 866
- **Publication date:** 2011-12-30
- **Effective date:** 2012-01-30
- **HHS docket:** Docket No. FDA-2011-D-0028
## 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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/12/30/2011-33588/medical-devices-ovarian-adnexal-mass-assessment-score-test-system-labeling-black-box-restrictions)
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