FDA Publishes List of Developers Who Can No Longer Legally Market Their COVID Test

FDA reiterates regulatory process for home tests & announces new funding mechanism

On May 27, 2020, 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 has now added to its FAQ page a list of developers who had previously been allowed to market under pathway D but have now been removed and are no longer allowed to market in the U.S. These developers were removed from the notification list because they did not submit their EUA after submitting their notification of intent to submit or because FDA reviewed their data and did not grant them authorization. Any developers with an asterisk on this list voluntarily asked FDA to remove them.
• As stated in the original guidance, certain kinds of tests must wait to market until they receive authorization from FDA under EUA. These tests include any intended for home collection of samples. Other pathways exist that allow marketing after the developer has notified FDA of intent to submit an EUA, meaning the developer can sell the tests while FDA reviews their application. FDA said that, internally, they prioritize any applications where the developers must wait for authorization to market their tests.
• A new funding mechanism for developers of diagnostic tests who need additional funding to complete the test development was announced. The Rapid Acceleration of Diagnostics (RADx) program is currently seeking proposals to rapidly produce innovative SARS-CoV-2 diagnostic tests.
• An additional extraction platform was added to the list of alternatives that can be used with the Centers for Disease Control and Prevention's (CDC) EUA-authorized tests, which is an important step to addressing reagent and kit supply limitations.
• FDA reported that the public should understand that the CE's equivalent EUA program for IVD tests is a self-certification and that a CE mark on a test does not necessarily mean the test has been independently reviewed. A CE mark does not enable tests to be distributed in the U.S.

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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, pathway D, or Umbrella Pathway submission for COVID-19 diagnostics. Our offerings also include reviewing diagnostic data to assess the completeness of the package for EUA, Umbrella Pathway, or pathway D submission.