federal_register: 2011-30552

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-30552 Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses." This guidance document provides industry and Agency staff with recommendations for studies to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of human papillomaviruses. 2011-11-28 2011 11 https://www.federalregister.gov/documents/2011/11/28/2011-30552/guidance-for-industry-and-food-and-drug-administration-staff-establishing-the-performance https://www.govinfo.gov/content/pkg/FR-2011-11-28/pdf/2011-30552.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses."...

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