FDA ends premarket review exception for COVID-19 laboratory developed tests

Nov 16, 2021 - 08:43 AM
FDA-guidance

To ensure that COVID-19 tests work as intended, the Food and Drug Administration will now enforce premarket review requirements for laboratory developed tests, reversing the prior administration’s policy, Health and Human Services Secretary Xavier Becerra announced yesterday. 

FDA said it generally intends to focus its review on emergency use authorization requests for at-home and point-of-care diagnostic tests that can be manufactured in high volumes; certain high-volume, lab-based molecular diagnostic tests and point-of-care antibody tests; and tests supported by federal stakeholders such as the Biomedical Advanced Research and Development Authority or National Institutes of Health. For details, see the FDA’s updated guidance for COVID-19 test developers during the public health emergency. 

Laboratory developed tests are developed, validated and performed by individual laboratories, including hospital laboratories, when commercial diagnostic tests do not exist or meet clinical needs. 
 

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