Q1: Can Emergency Use Authorizations (EUAs) continue after the public health emergency is over? If so, can FDA continue to issue EUAs after the public health emergency is over?
A: There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes.
People asking this question are usually referencing the declaration by the U.S. Department of Health and Human Services (HHS) Secretary that a public health emergency exists under section 319 of the Public Health Service (PHS) Act.
Under section 319 of the PHS Act, the HHS Secretary can issue a determination (also referred to as a “declaration”) that a “public health emergency” (PHE) exists.
- The declaration generally lasts for 90 days, but may be extended by the Secretary. After each extension, the declaration lasts for 90 days or until the Secretary declares the emergency no longer exists, whichever occurs first.
- A section 319 PHE declaration does not enable FDA to issue EUAs.
- A section 319 PHE declaration allows HHS to take appropriate actions in response to the emergency consistent with other authorities, including: making grants; entering into contracts; and conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder. For a more comprehensive list of what this type of declaration can enable, see from HHS: Public Health Emergency Declaration.
- HHS issued a section 319 PHE declaration in January 2020, and has extended it every 3 months since.
Separate declarations–sometimes referred to as “EUA declarations”—under section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act (also issued by the HHS Secretary) enable the issuance of EUAs.
Before FDA can issue an EUA, the HHS Secretary must declare that circumstances exist justifying the authorization. An EUA declaration is based on specific types of determinations, also under section 564, of emergencies/threats or potential emergencies/threats by the Secretaries of HHS, Homeland Security, or Defense.
- Unlike the section 319 PHE declaration that expires if not extended, an EUA declaration under section 564 generally continues until the HHS Secretary terminates it.
- An EUA declaration is distinct from, and not dependent on, an HHS PHE declaration under section 319 of the PHS Act, and, therefore, an EUA may remain in effect beyond the duration of the section 319 PHE declaration if all other statutory conditions are met.
- EUAs may remain authorized and new EUAs may continue being issued so long as the applicable EUA declaration and determination remains in effect.
- Whether FDA can continue to issue EUAs depends in part on whether any applicable EUA declarations, which are based on emergency/threat determinations under section 564 of the FD&C Act remain in effect.
- On February 4, 2020, HHS issued a determination under section 564 that there is public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus (nCoV) in 2019 (COVID-19). Based on that determination, HHS issued 4 EUA declarations, for:
If the Secretary terminates an EUA declaration, then any EUAs issued based on that declaration will cease to be in effect, and FDA may no longer issue EUAs for products covered by that declaration.
- Section 564(f)(2) of the FD&C Act notes certain instances where there can be continued use of the EUA product notwithstanding the termination of the EUA declaration or revocation of the EUA (see Transition period prior to termination and disposition of medical products in Question 2 below).
Q2: Once the public health emergency is over, what becomes of medical products (such as drugs, tests, vaccines) that have an EUA?
A: As noted above, An EUA declaration is distinct from, and not dependent on, an HHS PHE declaration under section 319 of the PHS Act, and, therefore, an EUA may remain in effect beyond the duration of the section 319 PHE declaration if all other statutory conditions are met.
If an EUA declaration is terminated, notice of termination will be published in the Federal Register. Before an EUA declaration is terminated, the Secretary will issue a Federal Register notice providing advanced notice to the public that the EUA declaration is being terminated. This starts the transition, which must be of a reasonable period to allow for proper dispositioning.
- For EUAs covering unapproved products, the transition will allow a sufficient period for proper dispositioning of the product.
- 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.
- Note: Under section 564(f)(2) of the FD&C Act, authorization of an unapproved product continues to be effective, even after termination of the EUA declaration or revocation of the EUA, to provide for continued use with respect to a patient to whom it was administered while the declaration remained effective (to the extent found necessary by the patient’s physician).
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. 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.
For medical devices, FDA issued a draft guidance, Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
A: In general, an EUA will remain in effect for the duration of the EUA declaration under which it was issued. There are two mechanisms, termination or revocation, that result in an EUA no longer being in effect:
- If an EUA declaration (under section 564 of the FD&C Act) is terminated, then all EUAs issued pursuant to that EUA declaration cease to be in effect on the date of the termination of HHS’s EUA declaration under section 564 of the FD&C Act (except in certain instances where there can be continued use of the EUA product in accordance with section 564(f)(2), as noted above).
- An individual EUA may be revoked by FDA (prior to termination of the EUA declaration supporting it) 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 the public health or safety.
Examples of circumstances that may make revocation appropriate to protect the public health or safety are described in the FDA Guidance Document: Emergency Use Authorization of Medical Products and Related Authorities.
FDA lists terminated and revoked EUAs on our website at:
- Emergency Use Authorization--Archived Information
- Historical Information about Device Emergency Use Authorizations
- Summary of Process for EUA Issuance
- Guidance: Emergency Use Authorization of Medical Products and Related Authorities
- From HHS: Public Health Emergency Declaration (about these declarations, under Section 319 of the PHS Act)
- From HHS: Public Health Emergency Declaration Q&As
- Draft Guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices (February 2022) - recording (1 hour, 28 minutes), transcript (PDF, 365 KB), and slides (PDF, 564 KB) available
- Information for Laboratories Implementing IVD Tests Under EUA
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2, including the Q&A: What will happen with tests offered under EUA if the public health emergency expires and is not renewed?
Consumers and general information: Contact FDA
You may also call 1-888-INFO-FDA / (1-888-463-6332)
Product sponsors: Contact the applicable FDA center with questions about a specific product or class of products
Other stakeholders: Contact AskMCMi@fda.hhs.gov with general questions about medical countermeasure emergency use authorities