federal_register: 2011-6622

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2011-6622 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the special controls guidance entitled "Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System." This guidance document describes a means by which the ovarian adnexal mass assessment score test system may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify these device types into class II (special controls). This guidance document is immediately in effect as the special control for the ovarian adnexal mass assessment score test system, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs). 2011-03-23 2011 3 https://www.federalregister.gov/documents/2011/03/23/2011-6622/guidance-for-industry-and-food-and-drug-administration-staff-class-ii-special-controls-guidance https://www.govinfo.gov/content/pkg/FR-2011-03-23/pdf/2011-6622.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the special controls guidance entitled "Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System." This guidance document describes a means...  

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