Objectives:

• List CLIA defined test complexities

• Differentiate between verification and validation of clinical laboratory tests

• Discuss regulated and non-regulated analytes

• Give an example of an alternative quality assessment

• Give an example of why an Emergency Use Authorization might be granted

To-do List

• Watch video lectures

• Read the following articles

  • Clinical Labs Air Concerns Regarding FDA's Draft LDT Guidance

  • AACC to FDA: Let labs run in-house coronavirus tests

• Listen to podcast: A Laboratory Risk Assessment during the Coronavirus (COVID-19) Pandemic

Navigating the Regulatory and Compliance Environment in Clinical Laboratory Testing

Overview of CLIA 88

Emergency Use Authorization

The Theranos Scandal