Special Report: What Next for COVID-19 Tests?

Federal laws allow the FDA to relax its normal stringent approval standards and authorize drugs, medical devices, laboratory tests, biologics, and other products on an accelerated and emergency basis during a public health emergency (PHE). The FDA has relied on that authority to provide Emergency Use Authorization (EUA) to 440 different COVID-19 tests and sample collection devices since the coronavirus PHE was declared at the start of 2020. However, that PHE is officially scheduled to end on May 11, 2023. And that begs a crucial question that directly affects all companies with COVID-19 testing products on the market: Can those tests still be produced and marketed after the PHE ends?

Public Health Emergency Law, 101

Some basic legal points that help explain the post-PHE fate of EUA COVID-19 tests:

As long as a PHE is in effect, HHS can give authority to clear new products meeting the needs of that emergency on an EUA basis. On February 4, 2020, HHS exercised that power with regard to COVID-19 products. More precisely, the department issued declarations allowing FDA to provide EUAs for four types of COVID-19 products:⁶

• • In vitro diagnostics

• • Personal respiratory protective devices

• • Medical devices

• Drugs and biological products

How the End of the PHE Affects EUA Tests

The end of the COVID-19 PHE on May 11 will not extinguish the validity of the EUAs issued for COVID-19 products. The reason for that is that HHS’ authority to issue the four EUA declarations for COVID-19 products comes not from Section 319 of the PHS Act but Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act.⁷ That means that the EUA declarations will remain valid after the PHE ends unless and until the Secretary ends them in accordance with the separate termination rules set out in the FD&C Act.

Unlike a Section 319 PHE which ends automatically if it is not extended, a Section 564 EUA declaration continues until the HHS Secretary expressly terminates it. In other words, while a PHE must exist for a Section 564 declaration to be issued, it can continue even after that PHE ends.

The good news for COVID-19 laboratories and test producers is that HHS has signaled that it will not pull the plug on the COVID-19 EUA declarations any time soon. On Jan. 31, one day after the Biden administration told Congress that it was ending the PHE, the FDA posted a notice reassuring stakeholders that EUA COVID-19 products will continue after May 11.⁸

“FDA recognizes that it will take time for manufacturers, health care facilities, providers, patients, and other stakeholders to transition away from EUA products and the policies that support them,” the notice states. “As we have recognized during the entire COVID-19 response, continued flexibility will be appropriate—while maintaining necessary oversight within our regulatory authorities under applicable laws—to support stakeholders during such transitions, while maintaining our high standards to protect consumers.”

Moreover, if and when the COVID-19 EUA declarations do come to an end, it will catch nobody by surprise. As the FDA notice explains, the HHS Secretary will first have to notify the public that it is terminating the EUA declarations by publishing a notice in the Federal Register. This will trigger a transition which must last for a reasonable period to allow for “proper dispositioning.”

“For EUAs covering unapproved uses of approved products,⁹ the transition will allow a sufficient period for proper dispositioning of any labeling or other materials associated with the authorization,” according to the notice. Authorization of an unapproved product remains effective after the EUA declaration terminates to allow for continued use with a current patient if that patient’s doctor considers it necessary.

Practical Impact on COVID-19 Test Makers and Laboratories

Eventually—but not immediately—laboratories and companies that are producing and marketing COVID-19 tests and other diagnostic products in the US will have to make a strategic decision: Get out of the business when HHS ends the EUA declarations or stay in it for the long haul by transitioning to full premarket approval.

The FDA has been calling on producers to take the latter course for almost as long as the HHS EUA declarations have been in effect. In December 2021, the agency issued draft guidance outlining a pathway for transitioning from EUA to full marketing and regulatory approval. The guidance recommends that manufacturers seeking full approval for their tests include in their submissions a transition plan for dealing with products that they have already distributed that includes:¹⁰

• • The estimated number of tests currently in distribution in the US

• • An explanation of how the manufacturer will dispose of products that it has already distributed if the FDA denies its application for marketing approval

• An explanation of how the manufacturer will deal with previously distributed products if the FDA approves the marketing submission

So far, manufacturers have been slow to wean themselves off EUA status. However, one company that has been active is BioFire Diagnostics. On March 17, 2021, the BioMérieux subsidiary secured the first traditional premarket approval for a COVID-19 diagnostic product when the FDA granted De Novo clearance to the BioFire FilmArray Respiratory Panel (RP) 2.1 run on the firm’s FilmArray 2.0 and higher-throughput BioFire Torch systems.¹¹ Less than a year later, the FDA provided 510(k) clearance to BioFire Defense’s COVID-19 Test 2, a rapid test developed in partnership with the U.S. Army Medical Materiel Development Activity’s Warfighter Protection and Acute Care Project Management Office.¹²

BioFire continues to lead the way. On February 3, 2023, the FDA announced that the BioFire Spotfire System and Spotfire Respiratory (Spotfire R) Panel for simultaneous detection of COVID-19 and other respiratory tract infection had received not only 510(k) clearance but also a CLIA waiver, making it the first COVID-19 test to be cleared via the CLIA waiver pathway.¹³ DiaSorin and Roche are the only other companies to secure premarket approval for COVID-19 tests previously cleared on an EUA basis.

COVID-19 EUA Tests that Have Received Full FDA Clearance

Date	Manufacturer	Product	Clearance Type
March 2021	BioFire Diagnostics	BioFire FilmArray Respiratory Panel (RP) 2.1	De Novo
Jan. 2022	BioFire Defense	COVID-19 Test 2	510(k)
Sept. 2022	DiaSorin	Simplexa COVID-19 Direct Kit COVID-19 PCR assay	510(k)
Oct. 2022	Roche	Cobas SARS-CoV-2 Qualitative PCR test	510(k)
Feb. 2023	BioFire Diagnostics	BioFire Spotfire System and Spotfire Respiratory (Spotfire R) Panel	510(k) and CLIA waiver

References:

1. 1. https://www.congress.gov/109/plaws/publ417/PLAW-109publ417.htm

1. 1. https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx

1. 1. https://aspr.hhs.gov/legal/PHE/Pages/covid19-11Jan23.aspx

1. 1. https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf

1. 1. https://www.federalregister.gov/documents/2020/03/18/2020-05794/declaring-a-national-emergency-concerning-the-novel-coronavirus-disease-covid-19-outbreak

1. 1. https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency

1. 1. https://www.congress.gov/115/plaws/publ92/PLAW-115publ92.htm

1. 1. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends

1. 1. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-approved-mcms

1. 1. https://www.fda.gov/media/155039/download

1. 1. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-sars-cov-2-diagnostic-test-using-traditional-premarket-review-process

1. 1. https://www.army.mil/article/253417/usammda_announces_fda_510_k_clearance_of_rapid_diagnostic_test_for_covid_19

1. 1. https://www.fda.gov/emergency-preparedness-and-response/about-mcmi/mcmi-news-archive