Modifications of FDA-cleared/approved tests
Author:
Affiliation:
1. University of Utah Health and ARUP Laboratories , Salt Lake City, UT , US
Publisher
Oxford University Press (OUP)
Subject
General Medicine
Link
https://academic.oup.com/ajcp/article-pdf/160/5/542/52783492/aqad081.pdf
Reference4 articles.
1. Laboratory-developed tests account for a small minority of tests ordered in an academic hospital system;Rychert;Am J Clin Pathol.,2023
2. Laboratory-developed tests: a legislative and regulatory review;Genzen;Clin Chem.,2017
3. Modification of in vitro diagnostic devices: leveling the playing field;Rychert;Clin Chem.,2020
4. FDA resumes move to regulate LDTs, likely setting up legal battle with lab industry;Bonislawski;360Dx,2023
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