NOTICE: VS Memorandum 800.73 Guidance on Diagnostic Kits

Veterinary Services (VS) Memorandum 800.73 was reissued on January 6, 2015, and is available on the Center for Veterinary Biologics (CVB) Web site at: CVB Newly Published Information.

 

VS Memorandum 800.73 provides guidance to licensees, permittees, and applicants to support an application for a U.S. Veterinary Biological Product License or U.S. Veterinary Biological Product Permit for diagnostic kits intended for the detection of animal disease or immunological status, as authorized by title 9 CFR part 101.2.

 

Diagnostic test kits are intended to detect the disease or immunological status of an animal. Kits must be validated to demonstrate the fitness for intended use. The kit, regardless of format or function, must be reliable, reproducible, and scientifically sound. The formal process for evaluating these kits—including diagnostic performance characteristics—is known as validation. This document outlines an approach for validating a diagnostic test, writing an Outline of Production, and confirming the expiration dating.

 

 

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