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FDA: EUAs for COVID-19 Lab Tests Will Continue after PHE Ends

by Glenn S. Demby | Feb 13, 2023 | Essential, FDA-nir, National Lab Reporter

Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.

Mass testing for covid 19 sars cov 2 infection concept several rapid antigen test istock image — iStock, aprott

With the expected end of the COVID-19 public health emergency (PHE) on May 11, labs will have to go back to complying with the normal pre-pandemic rules that applied before the Section 1135 blanket waivers issued by the U.S. Department of Health & Human Services (HHS) took effect.^1,2(See the related story). However, one thing that labs won’t have to worry about—at least not right away—is FDA emergency use authorization (EUA) for new COVID-19 tests. On January 31, the day after the Biden administration announced its intention to end the PHE, the FDA offered reassurance that it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.^3,4

EUAs After the PHE

The FDA outlined its position in the form of new Q&A guidance posted on the agency’s website. There are different kinds of emergency declarations that serve different purposes, the guidance explains. The PHE derives from Section 319 of the Public Health Service (PHS) Act, which allows the HHS Secretary to declare the existence of a PHE for 90 days unless it’s extended.⁵

However, while it creates the conditions allowing for it, FDA authority to issue EUAs for new products during an emergency isn’t based on a Section 319 PHE declaration, the guidance continues. FDA authority to clear products on an EUA basis comes from a specific declaration made by the HHS Secretary under Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. HHS issued such a 564 declaration for COVID-19 on February 4, 2020.^6,7 Based on that determination, HHS issued four declarations allowing FDA to provide EUAs for:

In vitro diagnostics;

Personal respiratory protective devices;

Medical devices; and

Drugs and biological products.

Unlike a Section 319 PHE declaration that ends automatically if it’s not extended, a Section 564 EUA declaration continues until the HHS Secretary expressly terminates it. Consequently, while a PHE must be in effect for a Section 564 EUA declaration, the declaration can remain in effect after that PHE comes to an end, the guidance explains.

Bottom Line: End of the PHE on May 11 won’t necessarily end EUAs for new COVID-19 products.

How EUAs Will Come to an End

The FDA also offers clarification on how the EUA termination process works if and when it’s activated. Specifically, there are two mechanisms: Termination: If an EUA declaration is terminated, all EUAs issued under the declaration cease to be in effect on the termination date. Revocation: Individual EUAs may also be revoked before the EUA declaration is terminated if:

The circumstances justifying issuance no longer exist;

The criteria for its issuance are no longer met; or

Other circumstances make revocation appropriate to protect public health or safety.

What Happens to Current EUA Products After the PHE Ends

The HHS Secretary will notify the public before terminating an EUA declaration by publishing a notice in the Federal Register, the guidance notes. 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, the transition will allow a sufficient period for proper dispositioning of any labeling or other materials associated with the authorization,” according to the guidance.⁸ Authorization of an unapproved product remains effective after the EUA declaration terminates to allow for continued use with a current patient if the patient’s physician considers it necessary.

“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 agency notes, promising to furnish support during the transition.

Takeaway

The FDA is signaling that labs and makers of EUA-cleared COVID-19 tests and other products will get a period to transition after the PHE ends. At that point, labs may have to decide between discontinuing or securing 510(k) or De Novo premarketing clearance for those products.