FDA Holds Second Town Hall Meeting to Clarify Emergency COVID-19 Diagnostics Development Guidance

Immediately in Effect for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff

April 17, 2020

The FDA held its second town hall-style meeting where the in vitro diagnostics community was invited to ask clarifying questions about the guidance on in-vitro diagnostics testing the FDA released on March 16, 2020, allowing emergency use authorization (EUA) for qualifying diagnostic tests for COVID-19.

The key takeaways from the town hall meeting on April 8, 2020, are listed below:

  • The FDA is aware of the accuracy issues for some of the serological tests. To combat this issue, they have formed an interagency partnership to provide third-party validation of the serological tests against a panel of COVID-19 positive and negative sera. Developers are encouraged to submit their serological tests for independent evaluation of detection accuracy. The FDA hopes to source enough sera that they will be able to send panels to developers as well and will make a further public announcement if this is possible.

  • The FDA clarified that, since the serological tests using pathway D of the guidance do not undergo evaluation through the EUA process, these tests can only be conducted in laboratories certified to perform high-complexity tests through the Clinical Laboratory Improvement Amendments (CLIA).

  • Manufacturers developing serological tests for use at the point-of-care must use the EUA process. As of April 8, 2020, the only authorized serological test (Cellex, Inc.) is for use in laboratories CLIA-certified for moderate- and high-complexity tests, not at the point-of-care.

  • Limits or waivers of some the Good Manufacturing Practices (GMP) requirements may be granted through the EUA process on a case-by-case basis, but GMP requirements such as presence of a complaint handling system and an adverse event reporting system must remain in place.

  • As of April 8, 2020, six states have been granted authority by the FDA to authorize COVID-19 tests under its own state law: Connecticut, Maryland, Mississippi, Nevada, New York, and Washington.

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How Exponent Can Help

Exponent’s multi-disciplinary team of biotechnology, medical device, and pharmaceutical industry professionals develop safety information for products and processes that comply with all pertinent standards, regulations, and best practices. With expertise in risk communication and Federal Drug Administration (FDA) assessments, Exponent can assist in FDA label preparation and pathway B or D submission for COVID-19 diagnostics. Our offerings also include reviewing diagnostic data to assess the completeness of the package for EUA or pathway D submission.

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:

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

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

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