CDC LOCS Lab Update: FDA and CMS Update on Pooling for Diagnostic and Surveillance Testing for SARS-CoV-2

June 30, 2020

The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have each recently posted information on their frequently asked questions pages about pooling procedures, particularly as they apply to COVID-19 surveillance testing.

View the FDA guidance here: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#clinical

View the CMS guidance here: https://www.cms.gov/files/document/06-19-2020-frequently-asked-questions-covid-surveillance-testing.pdf

This Lab Update was originally published by the CDC Laboratory Outreach Communication System (LOCS) here. Check out the CDC LOCS website and Coronavirus Disease 2019 (COVID-19) Information for Laboratories website for the latest information.

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The American Society for Clinical Pathology (ASCP) is a professional association based in Chicago, Illinois encompassing 100,000 pathologists and laboratory professionals. Founded in 1922, ASCP provides programs in education, certification and advocacy on behalf of patients, pathologists and laboratory professionals.

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