diagnostic

FDA is allowing for high complexity laboratory developed tests for COVID-19 testing.

March 13, 2020

McDermott+Consulting

Based on its review of the evidence, FDA has concluded that molecular-based laboratory developed tests (LDTs) that are authorized for use by the singular developing laboratory are appropriate to protect the public health or safety.

The FDA will issue EUAs for tests for use in the single laboratory that developed the test where the laboratory is CLIA certified to perform high complexity tests.

High Complexity Molecular-Based Laboratory Developed Tests

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