The regulatory landscape of laboratory developed tests: Past, present, and a perspective on the future-Reference-Cited by-同舟云学术

The regulatory landscape of laboratory developed tests: Past, present, and a perspective on the future

Published:2023-04 Issue: Volume:28 Page:67-69
ISSN:2667-145X
Container-title:Journal of Mass Spectrometry and Advances in the Clinical Lab
language:en
Short-container-title:Journal of Mass Spectrometry and Advances in the Clinical Lab

Author:

Budelier Melissa M.^ORCID,Hubbard Jacqueline A.^ORCID

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Medical Laboratory Technology,Spectroscopy,Microbiology

Reference14 articles.

1. T.M. Burton, n.d. FDA Backs Off Plans to Issue Rules Governing Lab-Developed Tests [WWW Document]. WSJ. URL http://www.wsj.com/articles/fda-backs-off-plans-to-issue-rules-governing-lab-developed-tests-1479529259 (accessed 12.28.22).

2. CLIA Law & Regulation [WWW Document], 2022. URL https://www.cdc.gov/clia/law-regulations.html (accessed 12.28.22).

3. COLA | The Joint Commission [WWW Document], n.d. URL https://www.jointcommission.org/what-we-offer/accreditation/health-care-settings/laboratory-services/cola/ (accessed 2.11.23).

4. D. DeGette, 2021. Text – H.R.4128 – 117th Congress (2021-2022): VALID Act of 2021 [WWW Document]. URL http://www.congress.gov/ (accessed 12.28.22).

5. S. Ehrmeyer, 2021. Regulations: An Overview, in: The New Poor Lab’s Guide to the Regulations. Westgard Quality Corporation, pp. 3–13.

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