FDA Updates Policy on COVID-19 Tests

The FDA has issued a revised guidance aimed at accelerating the development of COVID-19 tests by laboratories and commercial manufacturers.

The guidance describes two policies, one leading to an EUA submission to the FDA and the other not leading to an EUA submission when the test is developed under the authority of a state in which the laboratory resides.

The agency is allowing laboratories to use tests they develop and validate before the FDA has issued an EUA for their test, but states may also authorize tests in some situations.