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. 
 

Related News Articles

Headline
The Food and Drug Administration has revised its provider and recipient fact sheets for the Johnson & Johnson COVID-19 vaccine due to reports of…
Headline
The Centers for Medicare & Medicaid Services has approved a new Healthcare Common Procedure Coding System code J0248 for the VEKLURY (remdesivir) antiviral…
Headline
The Food and Drug Administration today announced that five months is the recommended interval between a primary dosing regimen and booster for Moderna’s…
Headline
Centers for Disease Control and Prevention Director Rochelle Walensky, M.D., last night recommended 12-15 year olds receive a single booster dose of the Pfizer…
Headline
COVID-19 vaccination during pregnancy was not associated with greater risk of preterm or small-for-gestational-age birth in a study comparing over 10,000 women…
Headline
Two new COVID-19 home tests are now available to consumers in the U.S. Tests from SD Biosensor and Siemens in December gained Food and Drug Administration…