As companies announce the marketing or development of diagnostic tests for the new coronavirus, they invariably reference an Emergency Use Authorization, or EUA.
U.S.-based Co-Diagnostics Inc CODX announced April 6 that its Logix Smart SARS-CoV-2 test received an EUA from the FDA, sending its shares higher by about 26%.
What Is EUA?
An EUA is accorded by the FDA under section 564 of the Federal Food, Drug and Cosmetic Act. It allows unapproved medical products or unapproved uses of approved medical products to be used in an emergency for diagnosing, treating or preventing serious or life-threatening diseases or conditions, especially when there are no adequate approved and available alternatives.
The emergencies are defined as a threat emanating from chemical, biological, radiological or nuclear material.
This definition underlines three aspects of the EUA:
- The case should be an emergency.
- The condition or disease for which the test or treatment is being developed should be life-threatening
- No approved or adequate alternative should be available.
Before the FDA issues an EUA, the Health and Human Services secretary must declare that circumstances exist to justify the authorization.
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Information, Data In An EUA Requisition
The FDA requires a well-organized summary of the following in EUA requests:
- Available scientific evidence regarding the product's safety and effectiveness.
- Risks, including an adverse event profile, and benefits.
- Any available approved alternatives to the product.
The FDA could seek additional data and information on a case-by-case basis.
Other data/information that support a request are:
- A description of the product and its intended use.
- The product's approval status.
- The need for the product.
- Information on chemistry, manufacturing and controls.
EUA Vs. Full Approval
The EUA is pertinent only as long as the emergency lasts. A full approval is for keeps, unless a safety or efficacy issue is identified that may lead to a reversal.
The FDA's review of a EUA is not as rigorous as that of a review for full approval.
In vitro diagnostic tests are usually approved by the FDA using one of the following three pathways:
- Premarket approval, a review to evaluate the safety and effectiveness of Class III medical devices, which are devices that support or sustain human life.
- Premarket notification, a notification to the FDA that the device to be marketed is as safe and effective as a legally marketed device at least 90 days before the intended period of commercialization.
- De novo classification, a pathway to classify novel medical devices for which there is no legally marketed predicate device.
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EUAs Issued For SARS-CoV-2
As of April 7, the FDA has issued EUAs for 29 in-vitro diagnostic tests for the new coronavirus.
Per the latest FDA guidelines, laboratories certified under the Clinical Laboratory Improvement Amendments can use validated tests for specimen testing for a reasonable period of time (estimated to be 15 business days) before an EUA is submitted.
Photo courtesy of Co-Diagnostics.
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