FDA Releases Updated Guidance on Diagnostics Testing as Response to COVID-19 Crisis

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

April 13, 2020

On March 16, 2020, the Federal Drug Administration (FDA) updated its guidance on diagnostics testing for COVID-19, outlining four pathways for diagnostic tests to be marketed in the United States:

  1. Laboratories Certified under Clinical Laboratory Improvement Amendments (CLIA) that Meet the CLIA Regulatory Requirements to Perform High-Complexity Testing

  2. State Authorization of Laboratories Certified under CLIA that Meet the CLIA Regulatory Requirements to Perform High-Complexity Testing

  3. Commercial Manufacturer Development and Distribution of Tests Prior to Emergency Use Authorization (EUA) Submission

  4.  Commercial Manufacturer Development and Distribution and Laboratory Development and Use of Serology Tests Without an EUA

This updated guidance was developed in an effort to enable COVID-19 diagnostics to be marketed in the United States as quickly as possible. Of note is the policy’s allowance for diagnostic tests to be marketed after FDA notification but before receiving emergency use authorization (EUA).

How Can Exponent 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 Holds Town Meetings to Clarify Recent COVID-19 Diagnostics Development Guidance