September 22, 2020
Diagnostic test developers might be impacted if validation requirements are not reviewed for completeness before IVD submissions
On August 19, 2020, the U.S. Food and 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:
- FDA has updated their FAQs pertaining to screening and asymptomatic testing. 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.
- 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 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 FDA is necessary for inclusion on the notification list outside of the submission of the application.
How Exponent Can Help
Exponent's multidisciplinary 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.