FDA in Need of Data, Warns Against Using Tests & Test Materials in Unintended Ways

IVD Testing / Response / Regulation

July 27, 2020

FDA warns against research use only materials being used inappropriately

On July 15, 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 discourages complete test kits labeled as Research Use Only (RUO) being sold or given to clinical labs. RUO kits may be supplied to researchers, though FDA encourages developers with RUO kits to submit an EUA to avoid improper use as a clinical diagnostic. FDA is encouraging labs to select their kits from manufacturers present on either the notified or authorized lists by the Agency, rather than using RUO materials. The notified and authorized lists can be found on FDA website. FDA encourages adherence to the guidance concerning RUO materials.
  • If a developer wants to add a claim for testing asymptomatic patients to their previously authorized test, they would have to include a study on the sample type of choice using at least 20 consecutively collected positive specimens and at least 100 consecutively collected negative specimens. Contrived samples are not acceptable for this purpose, and a certain percentage of the positive specimens collected must come from asymptomatic patients. The results obtained by the developer's test would need to be compared to the results obtained on the same sample set when testing using an authorized high-sensitivity assay. Additional details are now available in the Molecular Diagnostic Templates.
  • Serology tests are not currently used for immunity screening because the developer would have to claim that antibody presence equals immunity. Data proving immunity has not yet been generated.

How Exponent Can 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 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.