December 7, 2021
Updates to impact at-home, point-of-care, and laboratory diagnostic COVID-19 tests
On November 15, 2021, the U.S. Food & Drug Administration (FDA) updated the guidance "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency" aiming to increase the testing capacity of reliable at-home and point-of-care diagnostic tests. On that same day, the U.S. Department of Health & Human Services withdrew a policy that directed FDA not to enforce premarket review requirements for laboratory developed tests (LDTs). FDA will begin objecting to LDTs offered in the market without emergency use authorization (EUA) and has given laboratories a timeline for submitting the information necessary for remaining on the market, including a communication of intent to FDA within 45 or 60 days of the policy update.
In this policy update, FDA also announced its intention to focus its review on EUA requests on molecular and antibody tests with features including those designed as a multiplexed assay, used at home or in a point-of-care setting, and able to be pooled or capable of high-volume throughput.
FDA is prioritizing their review of tests requested or supported by a U.S. government stakeholder such as the National Institutes of Health RADx program.
Developers of other tests may consider traditional device review pathways, such as 510(k) notification or De Novo classification. FDA also updated its policies for viral transport media (VTM) and allows these manufacturers to distribute their products without the prior submission of a premarket notification; however, labeling requirements will be enforced.
How Exponent Can Help
Exponent's multidisciplinary team of invitro diagnostic professionals develop safety information for products and processes that comply with pertinent standards, regulations, and best practices. With expertise in analytic and clinical assessments, human factors, Software as a Medical Device (SaMD) regulations, artificial intelligence/machine learning, Clinical Laboratory Improvement Amendments (CLIA) compliance, quality system establishment, and FDA assessments, Exponent can assist in drafting or reviewing submission packages, auditing labs, or performing due diligence and validation/technical design of the assay, instrument, or collection kit. Our offerings also include reviewing diagnostic data to assess the completeness of the package for submission according to any of the EUA pathways or 510(k)/De Novo.