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
Health and Human Services Department, Food and Drug Administration
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This is a regulatory record from Health and Human Services Department, Food and Drug Administration — a rule, proposed rule, or notice. Regulations carry the force of law once final, and often invite public comment before that point.
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Key Details
- Posted Date
- NAICS Code
- 325412
- Source
- Federal Register
- Contract Type
- regulation
Description
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.
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