Devices

HHS Reverses FDA Policy on Lab-Developed Tests

David McFarland

— 2 min read
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HHS 11/15 withdrew a Trump Administration policy that directed FDA not to enforce premarket review requirements for laboratory developed tests (LDTs). FDA says the move is intended to help ensure that COVID-19 tests are accurate and reliable. 

The highly critical 8/20/2020 policy was part of the Trump Administration’s deregulation initiative, and was made without notice and comment rulemaking. At the time, Gail Javitt and Jeffrey Gibbs (Hyman, Phelps & McNamara) called the announcement “jaw-dropping” in a post in their firm’s FDA Law Blog. Under the policy, clinical laboratories were no longer required to submit a request for emergency use authorization (EUA) before offering LDT-based testing for Covid-19.

Under the new HHS framework, FDA has updated its policies regarding tests, including LDTs, currently being offered prior to or without authorization, as well as policies regarding the types of tests on which the FDA intends to focus its review. “Moving forward,” the agency says, “the FDA generally intends to focus its review on emergency use authorization (EUA) requests for the following types of tests:  

  • At-home and point-of-care (POC) diagnostic tests for use with or without a prescription and that can be manufactured in high volumes;
  • Certain high-volume, lab-based molecular diagnostic tests (and home collection kits for use with such tests) that expand testing capacity or accessibility such as through pooling of specimens to increase throughput, testing specimens collected at home and shipped to the lab, screening asymptomatic individuals or detecting multiple different respiratory viruses at once;
  • Certain lab-based and POC high volume antibody tests that can measure the amount of antibodies (fully quantitative antibody tests) or the amount of neutralizing antibodies; and 
  • Tests for which the request is from, or supported by, a U.S. government stakeholder, such as the Biomedical Advanced Research and Development Authority or the National Institutes of Health’s Rapid Acceleration of Diagnostics.”

FDA notes that developers of other tests may consider pursuing marketing authorization through traditional device review pathways such as the 510(k) or De Novo classification processes. 

Additionally, on 11/15 FDA reissued its Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) that indicates the agency “generally expects newly offered Covid-19 tests, including LDTs, to have an EUA, or traditional marketing authorization such as a granted De Novo or cleared 510(k), prior to clinical use...“For tests currently being offered without the submission of an EUA request, the FDA generally expects the submission of an EUA request as described in the guidance.  For such tests and notified tests with pending EUA requests, FDA generally intends to review the EUA requests and, if the test is not subsequently authorized, expects developers to cease marketing the test within 15 calendar days of being notified.”

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