FDA’s proposed rule for the regulation of laboratory-developed tests-Reference-Cited by-同舟云学术

FDA’s proposed rule for the regulation of laboratory-developed tests

Published:2024-02-14 Issue:2 Volume:62 Page:
ISSN:0095-1137
Container-title:Journal of Clinical Microbiology
language:en
Short-container-title:J Clin Microbiol

Author:

Miller Melissa B.¹^ORCID,Watts Mary Lee²,Samuel Linoj³^ORCID

Affiliation:

1. Department of Pathology and Laboratory Medicine, UNC School of Medicine , Chapel Hill, North Carolina, USA

2. American Society for Microbiology , Washington, DC, USA

3. Department of Pathology and Laboratory Medicine, Henry Ford Health , Detroit, Michigan, USA

Publisher

American Society for Microbiology

Link

https://journals.asm.org/doi/pdf/10.1128/jcm.01488-23

Reference29 articles.

1. Food and Drug Administration . 2023. Medical Devices; laboratory developed tests proposed rule. Available from: https://www.federalregister.gov/documents/2023/10/03/2023-21662/medical-devices-laboratory-developed-tests

2. Food and Drug Administration . 2014. Framework for regulatory oversight of laboratory developed tests; draft guidance for Industry food and drug administration staff and clinical laboratories notice. Available from: https://www.federalregister.gov/documents/2014/10/03/2014-23596/framework-for-regulatory-oversight-of-laboratory-developed-tests-draft-guidance-for-industry-food

3. Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests

4. Covid-19 Molecular Diagnostic Testing — Lessons Learned

5. Centers for Disease Control and Prevention . Pneumocystis pneumonia. Available from: https://www.cdc.gov/fungal/diseases/pneumocystis-pneumonia/index.html. Retrieved 10 Nov 2022.

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