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Review
. 2021 Aug:141:104875.
doi: 10.1016/j.jcv.2021.104875. Epub 2021 Jun 1.

What Every Clinical Virologist Should Know About The VALID Act On Behalf of the Pan-American Society for Clinical Virology Clinical Practice Com

Jane Hata  1 , Roberta Madej  2 , N Esther Babady  3
Affiliations
Review

What Every Clinical Virologist Should Know About The VALID Act On Behalf of the Pan-American Society for Clinical Virology Clinical Practice Com

Jane Hata et al. J Clin Virol. 2021 Aug.

Abstract

In 2018, a bi-partisan proposed draft legislation called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act was released by Representative Larry Bucshon (Republican-Indiana) and Diana DeGette, (Democrat-Colorado). The VALID Act attempts to create a new framework for the oversight and regulations of both laboratory-developed testing procedures (commonly known as laboratory-developed tests) and In vitro diagnostic tests by the U.S. Food and Drug Administration. The potential impact of this new law if passed may be significant for clinical laboratories in terms of diagnostic test development and implementation. In this report, we review the background and key information that every clinical virologist should know about the VALID Act.

Keywords: In vitro diagnostics; Lab-developed procedure; Test classification.

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Conflict of interest statement

Declaration of interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

References

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