March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:
- Developing a transition implementation plan,
- Submitting a marketing submission, and
- Taking other actions with respect to these devices.
The FDA encourages stakeholders to review the two final guidances, attend the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023
What is an EUA?
The FDA can use its Emergency Use Authorization (EUA) authority under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 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 U.S. Department of Health and Human Services (HHS) Secretary must make a declaration of an emergency, or a significant potential for an emergency and/or threat, justifying authorization of emergency use for a product. This chart summarizes the process for EUA issuance.
Please also see FAQs: What happens to EUAs when a public health emergency ends?
This page provides answers to frequently asked questions about EUAs and medical devices related to COVID-19.
Q: Once the section 319 public health emergency related to COVID-19 under the Public Health Service Act is over, what becomes of medical devices that have an EUA?
A: An EUA declaration under section 564 of the FD&C Act is distinct from, and is not dependent on, a public health emergency (PHE) declaration under section 319 of the Public Health Service Act (PHS Act). Therefore, an EUA may remain in effect beyond the expiration of a PHE declaration if other statutory conditions are met.
In general, 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. To help stakeholders prepare for termination of the device EUA declarations related to COVID-19, the FDA recommends manufacturers refer to the FDA guidance, Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).
The FDA may also revise or revoke EUAs for certain reasons, including when FDA determines that 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 the FDA's guidance, Emergency Use Authorization of Medical Products and Related Authorities, and in sections 564(f) and 564(g)(2) of the FD&C Act. Also see FAQs: What happens to EUAs when a public health emergency ends?
Sponsors of EUA devices are encouraged to follow up the EUA issuance with a marketing submission, if required, so that their products can continue to be distributed and/or remain on the market after the relevant device EUA declaration terminates and the EUA is no longer in effect.
Q: Will devices authorized under an EUA need to go off the market when the EUA declarations related to COVID-19 under section 564 of the FD&C Act terminate? Will they need a 510(k)?
A: The FDA has described general recommendations for devices issued EUAs related to COVID-19 to help manufacturers transition to normal operations in the FDA guidance Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidance describes a policy that when the relevant EUA declaration under section 564 of the FD&C Act is terminated, the FDA does not intend to object to the continued distribution of a device within the scope of the guidance where the manufacturer has submitted a marketing submission (e.g., 510(k), De Novo request, PMA) to the FDA and it is accepted by the FDA before the relevant EUA declaration terminates, and the FDA has not taken a final action on the marketing submission.
For additional information on recommendations on the transition plan with respect to devices issued EUAs related to COVID-19, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices, please see FDA's guidance, Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).
Additional information can also be found at FAQs: What happens to EUAs when a public health emergency ends?
Q: How do I know if the FDA has issued an EUA for a medical device?
A: For medical device EUAs, go to the Emergency Use Authorizations for Medical Devices webpage. This webpage lists current EUAs issued for medical devices relating to COVID-19, as well as EUAs relating to other emergencies/threats. For all EUAs issued by the FDA, refer to Emergency Use Authorization.
Q: Are FDA's reviews of 510(k) submissions for devices issued an EUA expedited?
A: The FDA is committed to providing timely access to critical devices to address COVID-19. CDRH will strive to meet goals established under the Medical Device User Fee Amendments for FY 2023- FY2027 (MDUFA V) for submissions made pursuant to section 510(k) of the FD&C Act.
Q: If an authorized device needs to be imported, do the importers need to register and list?
A: Importers must register and list if required by the device's EUA letter of authorization. Please review the following for additional information:
- Registration and Listing of Medical Devices Relating to COVID-19
- Importing Medical Devices Relating to COVID-19
- Importing COVID-19 Supplies
- Device Registration and Listing
Q: Can I modify my authorized device under the device's existing EUA?
A: Some changes may be permitted with the FDA's concurrence under the issued EUA, while other changes may require a new EUA. Therefore, before making a change to the device authorized under an EUA, a firm should contact the appropriate review team who reviewed the original EUA request to discuss the proposed change. In general, the Conditions of Authorization (usually Section IV) in the letter of authorization will provide information about what can be amended in the EUA with concurrence of the FDA.
Q: How do I get my medical device added to an EUA if an umbrella EUA for my device type has been issued?
A: The letter of authorization for an umbrella EUA for the device type will provide information about how an authorized product is added to a list. Keep in mind that some of these umbrella EUAs do not have lists maintained by the FDA. If your device does not meet the criteria to be authorized under an umbrella EUA, you may request an individual EUA.
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? Do I need an EUA?
A: The FDA's guidance, Emergency Use Authorization of Medical Products and Related Authorities, 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 submit a marketing submission under the appropriate regulatory pathway (for example, 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.
Your product type may also be the subject of a guidance document relating to COVID-19. If an EUA has not been issued, but your product type is the subject of a COVID-19-related guidance document, please refer to the information and recommendations in the guidance. Additionally, please refer to the Guidance Documents Related to Coronavirus Disease 2019 (COVID-19) (88 FR 15417) notice published in the Federal Register on March 13, 2023, for updates related to guidances issued during the COVID-19 PHE.
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).