FDA Announces Developers Submitting EUA Applications are Not Guaranteed Placement for Screening Test Authorization

Diagnostic Test Developers Might be Impacted if Validation Requirements are Not Reviewed for Completeness Before IVD Submissions

September 22, 2020

On August 19, 2020, the U.S. Food & Drug Administration (FDA) held its weekly town hall-style meeting where the in vitro diagnostics (IVD) community was invited to ask clarifying questions about the guidance on IVD testing last updated on May 4, 2020, allowing emergency use authorization (EUA) for qualifying diagnostic tests for SARS-CoV-2.

The key takeaways are listed below:

  • The FDA has updated their FAQs pertaining to screening and asymptomatic testing. The FDA expects developers to consult the templates for validation recommendations before submitting EUA applications with claims for asymptomatic tests. Healthcare providers do have the leeway to order tests not labeled for asymptomatic individuals and use them for screening purposes at their discretion.
  • The FDA has clarified that the “non-lab” designation includes tests authorized for home use, meaning users performing tests on themselves, and can be performed at home or somewhere else (schools, airports, etc.). The major defining feature of this test category is that it would not be performed within a Clinical Laboratory Improvement Amendments (CLIA)-certified lab.
  • The third direct antigen test was authorized, and the FDA continues to encourage EUA applications for direct antigen tests. Rapid turnaround tests with good sensitivities for patients with acute symptoms are needed to identify patient status quickly.
  • Submitting an EUA application does not automatically place a developer on the notification list. A separate contact point with the FDA is necessary for inclusion on the notification list outside of the submission of the application.

More information:

How Exponent Can Help

Exponent’s multi-disciplinary team of in vitro diagnostic, medical device, and pharmaceutical industry professionals develops safety information for products and processes that comply with pertinent standards, regulations, and best practices. With expertise in CLIA compliance, quality system establishment, and FDA assessments, Exponent can assist in reviewing submission packages, auditing labs or performing due diligence and validation/technical design of assays, instruments, or collection kits. Our offerings also include reviewing diagnostic data to assess the completeness of the package for submission according to any of the EUA pathways.

The FDA held town hall-style meetings for the in vitro diagnostics community can ask questions to clarify the FDA's recently issued guidance for developing diagnostic tests for SAR-CoV-2. To read more on the key takeaways from each meeting and how Exponent can help, please see the links below:

July 27, 2020 - FDA in Need of Data, Warns Against Using Tests/Test Materials in Unintended Ways

July 9, 2020 - FDA Continues to Fight Back Against Under-Performing COVID-19 Diagnostic Assays

July 9, 2020 - Supply Shortages Spark New Concerns as the FDA Receives Record Numbers of In Vitro Diagnostic EUA Applications

June 1, 2020 - Accuracy Issues Still Plague Developers While FDA Looks to At-Home Testing

June 1, 2020 - FDA Publishes List of Developers Who Can No Longer Legally Market Their COVID Test

May 18, 2020 - FDA Focusing on Accuracy for In Vitro Diagnostics for COVID-19

May 5, 2020 - FDA Holds Third Town Hall Meeting to Clarify Emergency COVID-19 Diagnostics Development Guidance

April 30, 2020 - FDA Discusses First Authorized Home Collection Kit

April 17, 2020 - FDA Holds Second Town Hall Meeting to Clarify Emergency COVID-19 Diagnostics Development Guidance

April 13, 2020 - FDA Holds Town Meetings to Clarify Recent COVID-19 Diagnostics Development Guidance

April 13, 2020 - FDA Releases Updated Guidance on Diagnostics Testing as Response to COVID-19 Crisis