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GAO: FDA Needs Policy to Avoid Repeating EUA COVID-19 Test Mistakes

by | Jul 20, 2022 | Diagnostic Testing and Emerging Technologies, FDA-dtet

In a recent report, the GAO says the agency needs a policy when it comes to enforcement discretion regarding tests approved via EUA.

The FDA needs to establish a policy on how it will use its enforcement discretion to increase laboratory test availability so that it is better prepared for the next public health emergency (PHE) and does not repeat the mistakes it made during the COVID-19 pandemic. That is the conclusion of a new report from the US Government Accountability Office (GAO) published on May 13.

FDA Efforts to Increase Availability of COVID-19 Tests

Because SARS-CoV-2 was an unknown virus, there were no laboratory tests for detecting it when the PHE began in late January 2020. As a result, the FDA had to bend its normal premarketing approval rules to ensure an adequate supply of tests reached the market. In so doing, the agency relied heavily on its authority to grant emergency use authorizations (EUAs) to temporarily allow use of unapproved medical products, as long as there’s evidence that:

  • The product may be effective to prevent, diagnose, or treat a serious or life-threatening disease or condition;
  • The product’s known and potential benefits outweigh its known and potential risks; and
  • There are no adequate, approved, and available alternatives to the product.

The agency also exercised enforcement discretion in allowing laboratories to use certain COVID-19 tests before they were authorized.

The good news is that the strategy succeeded in ensuring an adequate supply of tests. The bad news is that it allowed tests of dubious value to reach the market. According to the GAO, as of September 30, 2021, the FDA had exercised its enforcement discretion for 370 COVID-19 tests. Test developers submitted EUA requests for these tests, but FDA officials told the GAO that the agency hadn’t yet reviewed them. Instead, the agency monitored the performance of all COVID-19 tests reactively in response to performance problems, including false positive or negative results, reported by test producers, healthcare providers, and consumers for particular products. According to the GAO report, the FDA had received more than 18,000 such reports for COVID-19 tests by December 31, 2021.

As the numbers of unreviewed tests grew, FDA officials expressed concerns that the risks of the strategy could be outweighing the benefits. But it wasn’t until Nov. 2021 that the FDA updated its COVID-19 test policy with the intent of phasing out use of enforcement discretion and reducing the number of unauthorized tests.

The same thing could happen in the next public health emergency. As the GAO report notes, FDA did not have and still does not have a policy for when it should begin and end exercising enforcement discretion for the use of unauthorized tests. The absence of such a policy “could hamper an effective response and recovery during a crisis,” the report says.

Bottom Line

The GAO calls on the commissioner of the FDA to “develop a policy for the use of enforcement discretion regarding unauthorized tests in future public health emergencies” that addresses the conditions under which the agency would begin and end the use of such discretion. The report also indicates that the Department of Health and Human Services has concurred with the recommendation.


Here are some of the key new FDA EUAs and clearances that were announced in late June through mid-July 2022:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Healthy.io510(k) clearance for home use of iMinuteful kidney-damage test
Watmind USAEUA for Speedy Swab Rapid COVID-19 Antigen Self-Test
Genabio DiagnosticsEUA for at-home, over-the counter Genabio COVID-19 Rapid Self-Test Kit
PreventionGeneticsMarketing authorization for POMC/PCSK1/LEPR companion diagnostic as a Class II device
RocheEUA for Cobas SARS-CoV-2 Duo assay for use with Cobas 6800/8800 systems
Foundation Medicine (Roche subsidiary)Approval for FoundationOne CDx test as companion diagnostic with Roche's Rozlytrek (entrectinib) to identify patients with ROS1 fusion-positive non-small cell lung cancer or NTRK fusion-positive solid tumors that could benefit from Rozlytrek
LabCorpEUA for VirSeq SARS-CoV-2 NGS Test, first to get EUA for identifying and differentiating SARS-CoV-2 strains
Rune Labs510(k) clearance to use StrivePD app to monitor Parkinson's disease patients' symptoms via the Apple Watch
Sysmex America, Inc.Clearance for addition of residual white blood cell counting to its XN-10 Automated Hematology Analyzer with Blood Bank mode
Scopio Labs510(k) clearance for X100HT device with Full-Field Peripheral Blood Smear (PBS) Application to improve accuracy and speed of hematological tests
Thermo Fisher ScientificClearance for Thermo Scientific EliA RNA Pol III and EliA Rib-P tests for diagnosis of systemic sclerosis (SSc) and systemic lupus erythematosus (SLE)
AngleDe Novo clearance of Parsortix system for gathering cancer cells and analyzing blood samples from metastatic breast cancer patients