federal_register: 2011-6620

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2011-6620 Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System Rule The Food and Drug Administration (FDA) is classifying the ovarian adnexal mass assessment score test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System." The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for these devices. 2011-03-23 2011 3 https://www.federalregister.gov/documents/2011/03/23/2011-6620/medical-devices-immunology-and-microbiology-devices-classification-of-ovarian-adnexal-mass https://www.govinfo.gov/content/pkg/FR-2011-03-23/pdf/2011-6620.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying the ovarian adnexal mass assessment score test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled "Guidance for Industry...

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