{"database": "openregs", "table": "federal_register", "rows": [["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...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["2011-6621"], "units": {}, "query_ms": 12.833990971557796, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}