U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Emergency Situations (Medical Devices)
  5. Emergency Use Authorizations for Medical Devices
  6. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices
  7. FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic

What is an EUA?

 

During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.

Before the FDA can issue an EUA, the Secretary of Health and Human Services must make a declaration of emergency or threat justifying authorization of emergency use for a product. This chart summarizes the process for EUA issuance.

This page provides answers to frequently asked questions about EUAs and medical devices during the COVID-19 pandemic.

Q: How do I know if the FDA has issued an EUA for a medical device?

A: For EUAs for medical devices, go to Emergency Use Authorizations. This page lists current EUAs issued for medical devices during the COVID-19 pandemic as well as EUAs issued during previous public health emergencies.

For all EUAs issued by the FDA, refer to Emergency Use Authorization.

Q: Are 510(k) submissions for devices covered by an EUA also expedited?

A: The FDA is committed to providing timely access to critical devices to address the COVID-19 pandemic. EUA candidate products include medical products and uses that are not approved, cleared, or licensed under sections 505, 510(k), and 515 of the FD&C Act. CDRH will continue to strive to meet deadlines established under the FDA’s user-fee program for products submitted under 510(k). For products intended to address important public health issues related to COVID-19, CDRH will conduct its review as quickly as possible.

Q: If an authorized device needs to be imported, do the importers need to register and list?

A: No. Importers of devices authorized under an EUA do not need to register and list. For details, see Importing COVID-19 Supplies.

Q: What happens to authorized devices after the public health emergency is over?

A: The FDA may revise or revoke EUAs during a declared emergency for certain reasons, including if revising or revoking the EUA is appropriate to protect the public health or safety. More information on the duration of an EUA can be found in FDA’s guidance, Emergency Use Authorization of Medical Products and Related Authorities, and in sections 564(f) and 564(g)(2) of the Act. Sponsors of EUA products are encouraged to follow up the EUA with a premarket submission so that it can remain on the market once the EUA is no longer in effect.

Q: Will devices authorized under an EUA during this public health emergency need to go off the market? Will they need a 510(k)?

A: For medical products and uses that are not approved, cleared, or licensed under sections 505, 510(k), and 515 of the FD&C Act, manufacturers may submit the appropriate premarket submission to legally market their product after the EUA declaration is terminated or the EUA is otherwise revised or revoked. Manufacturers are encouraged to pursue premarket submissions through the appropriate regulatory pathway (e.g., 510(k), De Novo request, PMA) during the emergency so that devices can remain on the market after the emergency.

Q: Can I modify my authorized device under the device’s existing EUA?

A: Some changes may be permitted under the issued EUA, while other changes may require a new EUA. Therefore, before making a change to the product under an EUA, a firm should contact the appropriate review team who reviewed the original EUA request to discuss your proposed change. In general, the Conditions of Authorization (usually Section IV) in your letter of authorization will provide information about what can be amended in your EUA with concurrence of FDA.

Q: How do I get my medical device added to an EUA if an EUA for my device type has been issued?

A: The letter of authorization for the device type EUA will provide information about how an authorized product is added to a list. Keep in mind that some of these device type EUAs do not have lists maintained by FDA. If your device does not meet the criteria for issuance of a device type EUA, you may request an individual EUA. FDA’s guidance, Emergency Use Authorization of Medical Products and Related Authorities - Guidance for Industry and Other Stakeholders includes recommendations for what to include in an EUA request.

Q: I am a manufacturer of a product that is not the subject of an EUA. How do I submit a request for a new EUA?

A: FDA’s guidance, Emergency Use Authorization of Medical Products and Related Authorities - Guidance for Industry and Other Stakeholders contains information about how to determine if your product may be eligible for an EUA per the statutory criteria under Section B. EUA Medical Products, 1. Criteria for Issuance. As explained in the guidance, if you think your product may meet the criteria for issuance, you should assemble the information in Section D. Request for an EUA, 2. Information Recommendations. Not all types of products will meet the statutory criteria for an EUA. If your product does not meet the statutory criteria for an EUA, you may still submit a premarket submission under the appropriate regulatory pathway (e.g., 510(k), De Novo request, PMA) to legally market your product. You may also submit an application for an investigational device exemption (IDE) to study the use of your device during the emergency.

Your product type may also be the subject of a recent guidance document. If an EUA has not been issued, but your product type is the subject of a recent guidance document, please refer to the information and recommendations in the guidance.

Q: What are the criteria for products to be considered for an EUA?

A: FDA may issue an EUA if the criteria for issuance under section 564(c) of the Act are met. These criteria are explained and listed under Section B. EUA Medical Products, 1. Criteria for Issuance of the Emergency Use Authorization of Medical Products and Related Authorities - Guidance for Industry and Other Stakeholders.

Q: My product is the subject of an Investigational Device Exemption (IDE). Can I market my device while under an IDE if I feel that it would benefit patients during this public health emergency?

A: An IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. It does not permit the marketing of the product. For more details, see Investigational Device Exemption (IDE).

Back to Top