federal_register: 2011-6621
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011-6621 | Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions | Proposed Rule | The Food and Drug Administration (FDA) is proposing to amend 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. Elsewhere in this issue of the Federal Register, FDA is announcing a final rule that classifies the ovarian adnexal mass assessment score test system into class II (special controls). | 2011-03-23 | 2011 | 3 | https://www.federalregister.gov/documents/2011/03/23/2011-6621/medical-devices-ovarian-adnexal-mass-assessment-score-test-system-labeling-black-box-restrictions | https://www.govinfo.gov/content/pkg/FR-2011-03-23/pdf/2011-6621.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to amend 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... |