The Diagnostics Pipeline: FDA Unveils Plan to End COVID-19 Test Emergency Use Authorizations
On March 27, the agency released a new guidance document to help test developers make the transition to full approval.
With the public health emergency (PHE) scheduled to expire on May 11, laboratories and other developers that have benefited from relaxed clearance rules implemented by the FDA during the pandemic to bring new COVID-19 diagnostic tests to market face a choice: cease production or seek full regulatory approval for their products. On March 27, the FDA released a new guidance document to help test developers who select the latter option make the transition to full approval.1
How the End of the PHE Affects COVID-19 Diagnostics
Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) allows for the FDA to authorize emergency use of unapproved products for diagnosing, treating, or preventing a serious or life-threatening disease. To secure Emergency Use Authorization (EUA), product developers need to demonstrate that through fulfilling the following criteria: 2
- The product may be effective for such use
- The product’s known and potential benefits outweigh its known and potential risks
- There are no adequate, approved, and available alternatives
EUA clearance has thus been granted to nearly 450 different COVID-19 tests and sample collection devices since the COVID-19 PHE began. This EUA clearance won’t expire immediately when the PHE ends on May 11, the FDA guidance explains. The Secretary of Health and Human Services has provided assurances that he will publish an advance notice of when the FDA’s authority to issue EUA for COVID-19 products will end to give industry, providers, and patients time to prepare.3
From EUA to Full Marketing Approval
Before the official EUA termination date, which has yet to be announced, companies that want to keep marketing EUA devices will have to prepare a marketing submission for the FDA. Note that in FDA regulatory parlance, laboratory tests are a subset of what are referred to as “devices.” The device submitted for marketing approval and/or its labeling may be different from the current EUA device, the agency explains. For example, a company that distributed a singleplex assay under an EUA may decide to seek marketing approval for a multiplex assay.
Accordingly, the FDA recommends that companies include in the cover letter of their marketing submission a Transition Implementation Plan for dealing with devices already distributed in the event of either a positive or negative ruling on the marketing submission. The plan should list, among other things:
- The estimated number of devices under an EUA that are currently in US distribution
- A description of the company’s benefit-risk-based plan for dealing with distributed products in the event of a negative decision
- Where the company proposes to leave already distributed products in place, additional information about how the company will notify stakeholders of the device’s regulatory status, as well as a process and timeline for changes to the device or its labeling
The FDA acknowledges that transitioning to full marketing approval may take time. The FDA guidance indicates that the agency won’t object to the continued distribution of devices that are still undergoing review after their EUA ends, if the agency has previously accepted a marketing submission for the device. However, companies that do not make a marketing submission to the agency by the EUA termination date will have to stop marketing their devices on that date.
CLIA Categorization for EUA-Authorized in Vitro Diagnostics
In vitro diagnostics (IVDs) authorized under an EUA are generally cleared for use in specific settings, such as at the point of care or by laboratories that meet Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements for performing high or moderate complexity tests. Such CLIA settings authorizations last only for as long as the EUA is in effect, the guidance notes. Outside of EUAs, the FDA typically determines CLIA categorization only after approving the IVD’s marketing submission. The guidance explains how this will play out during the transition from EUA to approval of marketing submission:
- Moderate Complexity: The complexity of IVDs authorized under an EUA for moderate complexity laboratories will be determined immediately after final action on the marketing submission, as per the FDA’s usual categorization process.
- CLIA Waiver: Marketing submissions for IVDs with EUA for use in patient care settings operating under a CLIA Certificate of Waiver will have to go through either the Dual 510(k) and CLIA Waiver by Application pathway, or Dual De Novo and CLIA Waiver by Application pathway.
- Home Use: If a marketing submission for an IVD authorized by an EUA for home use gets clearance, approval, or authorization for home use, the test will be categorized as waived by regulation without the need for a CLIA Waiver by Application.
The guidance adds that the FDA does not, at this time, intend to object to continued distribution and use of IVDs authorized under an EUA for use in high complexity, moderate complexity, and waived settings, as long as the manufacturer has made a marketing submission for the test, even if the agency hasn’t made a final decision on the marketing submission or CLIA categorization.
Here are the key new laboratory testing and diagnostics product clearances that were announced from mid-March through mid-April 2023:
New FDA Approvals & Emergency Use Authorizations (EUAs)
|Magnolia Medical Technologies||510(k) clearance for 19 new configurations of Steripath Micro blood culture collection instruments|
|Leica Biosystems (subsidiary of Danaher)||510(k) clearance for BOND MMR Antibody Panel to identify Lynch syndrome in colorectal cancer patients|
|BioSynchronicity||EUA for point-of-care C-Sync COVID-19 Antigen Test|
|BioFire (subsidiary of BioMérieux)||510(k) clearance for Global Fever Special Pathogens Panel to detect bacterial, viral, and protozoan pathogens in people with suspected febrile illness|
|Abbott||510(k) clearance for update to real-time PCR-based Alinity m STI Assay for detection and differentiation of DNA from Neisseria gonorrhoeae and ribosomal RNA from Chlamydia trachomatis, Trichomonas vaginalis, and Mycoplasma genitalium|
|Healgen Scientific||510(k) clearance for Accurate Oral Fluid Drug Test lateral-flow chromatographic immunoassay for simultaneous detection of marijuana and cotinine (COT) consumption|
|Healgen Scientific||510(k) clearance for Accurate Oral Fluid Drug Test COT over-the-counter lateral-flow chromatographic immunoassay for detection of COT|
|Rapid Novor||CLIA waiver for EasyM, blood test for monitoring minimal residual disease (MRD) activity|
|DiaSorin||510(k) clearance for Simplexa COVID-19 & Flu A/B Direct, molecular assay for detecting and differentiating between SARS-CoV-2 and influenza A and B infections|
|Cue Health||EUA for Cue Mpox (Monkeypox) Molecular Test for use in point-of-care (POC) setting|
New CE Marks & Global Certifications
Notable European CE certifications announced during the period:
New Approvals in Europe
|Q’Apel Medical||Walrus balloon guide catheter to arrest blood flow during procedures to remove blood clots in the brain|
Other international clearances announced during the period:
|bioLytical Laboratories||Canada||INSTI multiplex HIV-1/2 Syphilis Antibody Test|
|Lucira Health||Australia||COVID-19 & Flu Home Test at-home molecular diagnostic combo assay to detect influenza and COVID-19|
|Amoy Diagnostics||Japan||AmoyDx Pan Lung Cancer PCR Panel as a companion diagnostic to direct the use of Eli Lilly’s Retevmo (selpercatinib) in RET fusion-positive non-small cell lung cancer|
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