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

FDA Reiterates Regulatory Process for Home Tests and Announces New Funding Mechanism

June 1, 2020

On May 27, 2020, the 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:

  • The 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 the FDA reviewed their data and did not grant them authorization. Any developers with an asterisk on this list voluntarily asked the FDA to remove them.
  • As stated in the original guidance, certain kinds of tests must wait to market until they receive authorization from the FDA under the EUA. These tests include any intended for home collection of samples. Other pathways exist that allow marketing after the developer has notified the FDA of intent to submit an EUA, meaning the developer can sell the tests while the FDA reviews their application. The 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 CDC’s EUA-authorized tests, which is an important step to addressing reagent and kit supply limitations.
  • The 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.

More information:

  • The FDA is routinely updating its FAQ page on diagnostic testing for SARS-CoV-2, which can be found here.
  • A full recording of the meeting can be found here.
  • Use the MedWatch system to report any suspected issues with COVID-19 IVD tests, found here.
How Exponent Can 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 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.

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:

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