Point-of-care testing methods of all complexity levels are subject to the rigors of Food and Drug Administration (FDA) approval before utilization in the workplace. Specific scenarios in the healthcare industry require that diagnostic and direct patient care items be released before the completion of all evaluations included in the FDA evaluation process. The release of these products follows a process labeled Emergency Use Authorization (EUA). A EUA is described as a process whereby the "FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases.... when certain criteria are met including there are no adequate, approved, or available alternatives." (Emergency Use Authorization.
www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization). EUA may be utilized for POCT methods under the above-described scenarios.
The test method or kit will be provided with written instructions and test complexity designation. The facilities utilizing the test methods must follow all written guidelines and requirements provided by the manufacturer.
