federal_register: 2011-33588
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011-33588 | Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions | Rule | 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. | 2011-12-30 | 2011 | 12 | https://www.federalregister.gov/documents/2011/12/30/2011-33588/medical-devices-ovarian-adnexal-mass-assessment-score-test-system-labeling-black-box-restrictions | https://www.govinfo.gov/content/pkg/FR-2011-12-30/pdf/2011-33588.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | 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... |