FDA Fires Back at Claims of Inefficiency During the Pandemic While Guiding Developers Seeking Asymptomatic Claims

Developers of Diagnostic Tests Might Find Solutions to Lack of Asymptomatic Samples or Incentive to Creatively Report Results in FDA’s Recommendations

October 14, 2020

On September 9, 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 emergency use authorization (EUA) process for SARS-CoV-2 diagnostic tests.

The key takeaways are listed below:

  • Dr. Timothy Stenzel, Director of the FDA Office of In Vitro Diagnostics and Radiological Health, and a key resource during these town hall meetings, has published an opinion piece on the efforts of the FDA during the pandemic. The article responds to criticism of inefficiency at the FDA and describes how the Agency has chosen to balance flexibility with developers and safety for the public.

  • Adding a claim that a test will work on asymptomatic populations requires validation data, including an FDA-recommended minimum of 20 asymptomatic patient samples. The FDA acknowledges that asymptomatic samples are difficult to find and offers the flexibility of having half the samples be asymptomatic and the other half be matched symptomatic samples. For details on matching, reach out to the FDA for advice and approval on a recommended study design. Validation with less than the recommended minimum data with asymptomatic individuals may require post-market studies.

  • Many college campuses are engaging in large-scale screening and surveillance testing programs. The FDA prompted developers in need of samples from asymptomatic individuals to work with those programs and within local regulations to enroll patients for validation studies. The FDA cautions that whoever is collecting and testing the samples from the asymptomatic individuals should be blinded to whether the sample is positive or negative.

  • Tests performed in locations without CLIA certifications (e.g., in the home) are not legally required to report their positive or negative results to public health authorities. However, the FDA noted that they are actively encouraging developers to pair their diagnostic tests with reporting mechanisms. Popular methods have been via the connectivity inherent in the testing instrument or through an app designed for that purpose. Any reporting functionality or accompanying product ancillary to the diagnostic test itself will also require validation.

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 can assist with aspects of technical design, verification, and validation of the assay, instrument, or collection kit. 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 to 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:

October 9, 2020 - False Positive Rates for COVID-19 Diagnostics Could Have Dire Unintended Consequences When Used for Screening in Certain Populations

September 22, 2020 - FDA Announces Developers Submitting EUA Applications are Not Guaranteed Placement for Screening Test Authorization

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