Current regulatory landscape for viral point-of-care testing in the United States

Author:

Shirley Joshua D.ORCID,Bennett Shannon A.,Binnicker Matthew J.

Publisher

Elsevier BV

Subject

Infectious Diseases,Virology

Reference24 articles.

1. World Health Organization. The top 10 causes of death. https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death (October 20, 2022).

2. Centers for Disease Control and Prevention. Deaths and mortality. https://www.cdc.gov/nchs/fastats/deaths.htm (October 20, 2022).

3. World Health Organization. WHO coronavirus (COVID-19) dashboard. https://covid19.who.int/(October 20, 2022).

4. Vitro Diagnostics EUAs,2022

5. U.S. Food & Drug Adminstration. Recommendations for clinical laboaratory improvement amedments of 1988 (CLIA) waiver applications for manufactures of in vitro diagnostic devices. 2020 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-clinical-laboratory-improvement-amendments-1988-clia-waiver-applications.

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