federal_register: 2017-19612
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2017-19612 | Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) 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 provides recommendations to facilitate study designs to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of human papillomaviruses (HPVs). This guidance replaces a previously issued final guidance entitled "Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection, or Detection and Differentiation of Human Papillomaviruses," dated November 28, 2011. | 2017-09-15 | 2017 | 9 | https://www.federalregister.gov/documents/2017/09/15/2017-19612/establishing-the-performance-characteristics-of-in-vitro-diagnostic-devices-for-the-detection-or | https://www.govinfo.gov/content/pkg/FR-2017-09-15/pdf/2017-19612.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) 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... |