June 29 LOCS (CDC) Email

Subject: FDA and CMS Update on Pooling for Diagnostic and Surveillance Testing for SARS-CoV-2
Audience: Clinical Laboratory Professionals
Level: Laboratory Update

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

Online resources: