![]() ![]() ![]() The term POC can generally be used to refer to near-patient testing with tests that are high, moderate, or waived complexity.Īs discussed in the Guidance for Industry and Other Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities, when the FDA issues an EUA for a test, it can indicate whether the test can be performed at a POC setting or only in a laboratory able to handle more complex tests. Point-of-care (POC) settings include a variety of settings where testing can be performed near the patient, without transporting the sample for processing elsewhere, such as hospitals, physician offices, urgent care, outreach clinics, pharmacies, and temporary patient care settings that have appropriately trained personnel to perform the test. Laboratories authorized to use EUA-authorized tests are subject to various conditions that can be found in the EUA. ![]() Such laboratories may perform tests for which they meet the qualifications of the authorized settings included in the authorization.Facilities, including point-of-care settings such as health clinics, that perform COVID-19 testing must be certified as a laboratory under the Clinical Laboratory Improvement Amendments, or CLIA, which is administered by the Centers for Medicare & Medicaid Services (CMS ).The setting in which each test is authorized is also included in the tables of COVID-19 tests granted traditional marketing authorizations. In addition to COVID-19 tests issued EUAs, there are SARS-CoV-2 tests that have been authorized through traditional premarket review pathways. Tests noted with an "H," "M," and "W" may be used in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests and in patient care settings operating under a CLIA Certificate of Waiver.Tests that are noted with a "W" in the Authorized Settings are deemed to be CLIA-waived for use in patient care settings operating under a CLIA Certificate of Waiver.Tests that are noted with an "H" and "M" in the Authorized Settings may be performed in laboratories certified under CLIA to perform high complexity and/or moderate complexity tests.Tests that are noted with an "H" in the Authorized Settings are limited to use in laboratories certified under CLIA that meet requirements to perform high-complexity tests.The settings authorized in the EUAs are also noted in the EUA tables on the In Vitro Diagnostics EUA page. A: Each Emergency Use Authorization (EUA) for a COVID-19 test includes the settings in which the test is authorized. ![]()
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