EUA – Emergency Use Authorization Explained

The FDA (Federal Drug Administration) has strict guidelines for the approval and release of any products designed for human use. These guidelines must be accommodated for a product to be approved and available to the public. However, when a declaration of emergency has been issued, as in the case of the COVID-19 pandemic, the FDA has the authority to issue “EUA” referrals for medical products. These are not standard “FDA approvals” but instead, a release of specific products that have gone through EUA referral requirements and received an EUA certificate.

Pursuant to section 564 of the FD&C (Federal Food, Drug and Cosmetic Act), On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) justified the authorization of emergency use of in vitro diagnostics for the diagnosis/detection of the COVID-19 virus (known as SARS-Co-V-2), personal respiratory protective devices (March 2, 2020), or other medical devices including alternative products used as medical devices on (March 24, 2020). The basis of the declaration was that there is a public health emergency that is of significant potential to affect the health and security or national security of U.S. citizens living abroad. The use of all EUA products during the COVID-19 pandemic is pursuant to section 564 and is subject to the terms of any authorization issued under that section.

The process of application and approval for EUA products is detailed and very specific for each type of product that a company is applying for. The purpose of the application, analysis and EUA approval is for health and safety and may include both new products and those previously submitted to the FDA for approval.

Declaration of Emergency Determinations:

There are specific guidelines established for the determination of a national emergency that include:

•A determination by the Secretary of Homeland Security that there is an actual or significant potential for a domestic emergency involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent(s);

•A determination by the Secretary of Homeland Security of a material threat of a chemical, biological, radiological or nuclear agent sufficient to affect national security or the health and security of United States citizens living abroad;

•A determination by the Secretaryof Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, of attack with (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces; or

•A determination by the Health and Human Services Secretary that there is a public health emergency or a significant potential for a public health emergency that affects, or has significant potential to affect, national security or the health and security of U.S. citizens living abroad and involves a biological, chemical, radiological, or nuclear agent(s) or disease or condition that may be attributable to such agent(s).

Conditions for FDA Issued Products:

FDA may then issue an EUA for a product if FDA finds that:

•the agent specified in the declaration of emergency can cause a serious or life-threatening disease or condition;

•based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition, or a serious or life-threatening disease or condition caused by a product authorized approved, cleared, or licensed by FDA for diagnosing, treating, or preventing the disease or condition;

•the known and potential benefits of the product outweigh the known and potential risks of the product when used to diagnose, prevent, or treat the serious or life-threatening disease or condition, taking into consideration the material threat posed by the agent or agents identified in a declaration by the DHS Secretary, if applicable;

•there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such serious or life-threatening disease or condition; and

•in the case of a determination by the Secretary of Defense regarding risk to U.S. military forces from agents other than chemical, biological, radiological and nuclear agents, that the request for emergency use is made by the Secretary of Defense.

How to Tell if a Product is EUA-Certified

Once the COVID-19 pandemic was announced as a national emergency, a number of less than ethical companies tried to sell their unauthorized products. The FDA has quickly caught and fined these companies, removing their ability to put their products on the market.

All EUA-authorized entities will receive an EUA Certificate for each product that was applied for an approved under the EUA guidelines. An entity/company should have a copy/copies of those certificates available on their website and/or be able to supply copy(ies) to anyone that requests them.

In Vitro COVID-19

It must first be noted that any/all EUA certified products are for temporary emergency use only and do not have full FDA approval. In vitro diagnostic devices are the products used to perform tests on samples that are taken from the human body. Examples of these tests can include but are not limited to mucus swabs from inside of the nose or back of the throat as well as blood taken from a fingerstick or vein or other specific fluids that are used for the purpose of monitoring a patient’s overall health to assist in treatment or cure, or to prevent diseases. The IVDs used for SARS-CoV-2 and Covid-19 include:

•Diagnostic Tests: These are tests that detect portions of the SARS-CoV-2 virus that can be used as a diagnosis for virus infection. Diagnostic tests include both molecular and antigen tests.

•Serology/Antibody Tests: These are tests designed for the detection of the antibodies such as IgM and IgG for the SARS-CoV-2 virus. Serology/Antibody tests cannot be used as a basis for diagnosing a current infection.

•Tests for COVID-19 Patient Management: In addition to the SARS-CoV-2 virus diagnosis or antibody detection tests, there are other tests that have been authorized for the use of managing COVID-19 patients. An example of these tests include those that detect inflammation biomarkers. Once a patient has a confirmed diagnosis of COVID-19, the additional tests can be a basis for decisions on informed patient management.

EUA Product Authorization

To assure that only safe and effect products are included as part of the EUA, the process of applying for and receiving EUA product authorization is extensive. A complete list of the requirements can be found on the FDA download.

Here is the initial information required for EUA product authorization:

FDA recommends that a request for an EUA include a well-organized summary of the available scientific evidence regarding the product’s safety and effectiveness, risks (including an adverse event profile) and benefits, and any available, approved alternatives to the product. The exact type and amount of data needed to support an EUA may vary depending on the nature of the declared emergency or threat of emergency and the nature of the candidate product. FDA may seek additional data and information on a case-by-case basis to ensure that the statutory criteria for issuance of an EUA are met. 25 FDA recommends that the following information be submitted in any request for an EUA:

• A description of the product and its intended use (e.g., identification of the serious or life-threatening disease or condition for which the product may be effective; where, when, and how the product is anticipated to be used; and/or the population(s) for which the product may be used); A description of the product’s FDA approval status (e.g., whether the product is unapproved or whether it is approved but the EUA is for an unapproved use); whether the product or intended use is under an investigational application (e.g., if an IND/IDE is in effect or has been submitted; whether the product is approved in a foreign country for either the proposed use or another use; information on the use of the medical product by either a foreign country or an international organization (e.g., the World Health Organization (WHO));

• The need for the product, including identification of any approved alternative product(s) and their availability and adequacy for the proposed use, and the unmet need(s) the EUA would address;

• Available safety and effectiveness information for the product (discussed in more detail below); • A discussion of risks and benefits, including available information concerning the threats posed by the CBRN agent(s) involved (discussed in more detail below within this section);

• Information on chemistry (as applicable), manufacturing, and controls; a list of each site where the product, if authorized, is or would be manufactured, and the current CGMP status of the manufacturing site(s);

• Information about the quantity of finished product on hand and the surge capabilities of the manufacturing site(s);

• Information comparable to an FDA-approved package insert or instructions for use; drafts of the “Fact Sheets” to be furnished to health care professionals or authorized dispensers26 and recipients of the product, which typically are part of pre-EUA discussions (see section III.E.1 of this guidance); and a discussion of the feasibility of providing such information in an emergency;

If seeking an extension of a product’s labeled expiration date, any available information in support of such an extension27 (e.g., information on product stability such as test results; prior and anticipated storage and handling conditions; the lots, batches, or other units affected; any prior expiration date extensions; and for medical devices, an explanation of labeled expiration date, such as whether the inclusion of such information was based on a premarket requirement, requirements of another regulatory body, or a business decision); and

• Any right of reference28, as applicable.

In addition, any developer of a test that requests an EUA that will be leveraging data from another EUA-authorized device is required to obtain a right of reference for the purpose of leveraging the performance data for that particular EUA-authorized device. The CDC (Centers for Disease Control and Prevention) has granted a right of reference in FDA submission number EUA200001, for performance data in the EUA request for an entity that is seeking an FDA EUA diagnostic device for COVID-19.