FDA releases guidance on diagnostic testing for COVID-19, effective immediately

The United States Food and Drug Administration (FDA) has issued guidance to provide a diagnostic testing policy for novel coronavirus, SARS-CoV-2, used in labs certified to perform high complexity testing under the Clinical Laboratory Improvement Amendments (CLIA). This policy comes into effect prior to the FDA issuing emergency use authorizations (EUAs) for such diagnostic testing, enabling laboratories to use tests they develop faster to achieve more rapid testing capacity in the United States.

How TSG can help

TSG’s consultants have expertise in reviewing protocols, as well as the molecular and biochemical data of ingredients to determine product efficacy.

If you are developing a novel coronavirus (COVID-19) molecular diagnostic testing kit, get in touch at [email protected] to find out how we can assist.

Click here to visit the FDA’s website and learn more about the policy. Click here to read the full policy on the Federal Register.