April 13, 2020
Immediately in effect Guidance for Clinical Laboratories, Commercial Manufacturers plus Food & Drug Administration Staff
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:
- Laboratories Certified under Clinical Laboratory Improvement Amendments (CLIA) that Meet the CLIA Regulatory Requirements to Perform High-Complexity Testing
- State Authorization of Laboratories Certified under CLIA that Meet the CLIA Regulatory Requirements to Perform High-Complexity Testing
- Commercial Manufacturer Development and Distribution of Tests Prior to Emergency Use Authorization (EUA) Submission
- 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 multidisciplinary 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.