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2. Laboratory-Developed Tests: A Legislative and Regulatory Review;Genzen;Clin Chem,2017
3. Regulation of Laboratory-Developed Tests;Genzen;A Clinical Laboratory Perspective, Am J Clin Pathol,2019
4. Center for Medicare and Medicaid Services (CMS). State Operations Manual Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services, https://www.cms.gov/Regulations-and Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf, Accessed 11/20/22.
5. What is CMS’ authority regarding Laboratory Developed Tests (LDTs) and how does it differ from FDA’s authority?, CLIA FAQs, https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/ldt-and-clia_faqs.pdf, Accessed 11/20/22.