Since the start of the COVID-19 PHE, the FDA has been committed to providing timely recommendations and regulatory information to support response efforts, and important tools and flexibilities to manufacturers, health care facilities, providers, patients, and other stakeholders. The FDA remains committed to providing notice and information to all impacted stakeholders to ensure a smooth transition.
Importantly, the ending of the PHE declared by HHS under the PHS Act will not impact FDA’s ability to authorize devices (including tests), treatments or vaccines for emergency use. Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met.
For additional resources from HHS, see: COVID-19 Public Health Emergency (PHE).
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 HHS Secretary. After each extension, the declaration lasts for 90 days or until the HHS 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.
- The HHS Secretary issued a section 319 PHE declaration for COVID-19 in January 2020, and extended it every 3 months until May 11, 2023.
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 the FD&C Act, 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 of the FD&C Act 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.
- The HHS Secretary issued a determination under section 564 of the FD&C Act (initially issued February 4, 2020, and amended March 15, 2023) that there is a public health emergency, or significant potential for a public health emergency, that affects or 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 the HHS determination, HHS issued 4 EUA declarations, for:
On March 17, 2023, HHS issued a notice that, effective March 15, 2023, the HHS Secretary amended the February 4, 2020 determination made pursuant to section 564 of the FD&C Act and determined pursuant to his authority under section 564(b)(1)(C) that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad and that involves a biological agent, namely the novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (SARS-CoV-2).
The four previously-issued section 564 declarations that refer to the February 4, 2020 determination have not been terminated by the Secretary because, among other things, the circumstances described in section 564(b)(1) continue to exist—i.e., COVID-19, a disease attributable to SARS-CoV-2, continues to present a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad. Consistent with section 564(f), the currently-in-effect EUAs issued under those section 564 declarations remain in effect until the earlier of the termination of relevant section 564 declarations under section 564(b), or revocation of the EUAs. Therefore, these EUAs, including for tests, other devices, treatments, and vaccines, continue to remain in effect.
If the HHS 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 under the PHS Act 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, a 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 HHS Secretary will issue a Federal Register notice providing advance 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 from EUA devices and the policies that support them. FDA developed the Transition Plan for Medical Devices Issued EUAs Related to COVID-19 to describe a transition plan, among other things, to help avoid disruption in device supply and help facilitate compliance with applicable FD&C Act requirements after the termination of the relevant device EUA declaration related to COVID-19.
For medical devices issued EUAs related to COVID-19, see FDA's guidance, Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).
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) of the FD&C Act, 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: 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
Q4: What is the impact of PHE termination on FDA guidance documents?
A: In the Federal Register of March 13, 2023, FDA published a notice addressing the Agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the PHE, and which of those guidance documents FDA is revising to temporarily continue in effect. The FDA web page, COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders, has been updated to list only the COVID-19 guidances that remain in effect at this time.
- Summary of Process for EUA Issuance
- Guidance: Emergency Use Authorization of Medical Products and Related Authorities
- From HHS: Public Health Emergency Declaration Q&As
- From HHS: COVID-19 Public Health Emergency (PHE), including resources and fact sheets about the transition
- From HHS: Fact Sheet: End of the COVID-19 Public Health Emergency (May 9, 2023)
- From HHS: PREP Act Questions and Answers - COVID-19, including "How does the end of the PHE affect PREP Act coverage for COVID-19 countermeasures?"
- Guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Webinar on Final Guidances on Transition Plans for COVID-19 Related Medical Devices (April 2023) - recording (1 hour, 28 minutes ), transcript (PDF, 361 KB), printable slides (PDF, 979 KB)
- Information for Laboratories Implementing IVD Tests Under EUA
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
- FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic
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