Registration and Listing of Medical Devices Relating to COVID-19
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
This page provides information for medical device establishments, including owners and operators of places of business (also called facilities for purposes of this page) that are involved in the production (e.g., manufacturing, assembling, or processing) and distribution of medical devices that are authorized by Emergency Use Authorizations (EUA) or that are the subject of one of FDA’s COVID-19 guidance documents.
In general, most facilities that are required to register with FDA are also required to list the devices they manufacture, prepare, propagate, compound, assemble, or process and the activities they perform on such devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE, De Novo) when they register with FDA. This page answers frequently asked questions about procedures and requirements concerning the registration of facilities and the listing of devices during the COVID-19 pandemic.
On this page:
- Registration and Listing of Medical Devices Relating to COVID-19
- Confirming Registration and Listing Information
- Registration and Listing of Certain Medical Devices During the Emergency
Registration and Listing of Medical Devices Relating to COVID-19
Q: Does FDA have any policies or recommendations concerning registration and listing for facilities of medical devices intended for use relating to COVID-19?
A: During the COVID-19 pandemic, the FDA took action to help ensure that critical medical devices were available for use. For example, the FDA issued Emergency Use Authorizations (EUAs) for critical devices such as certain infusion pumps, remote monitoring devices, personal protective equipment (PPE) devices, such as N95 respirators, and in vitro diagnostics. To view EUAs for specific devices, see Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices. If your device has an EUA, you should review the EUA letter of authorization to determine whether the FDA requires you to register and list.
A facility that registers is required to pay the annual registration user fee prior to registering the facility or listing a device. The process for registering and listing is described at Device Registration and Listing.
Q: How does a facility register and list a device?
A: For step-by-step instructions on how to register and list a device, please see How To Register and List. For tutorials on FDA Unified Registration and Listing System (FURLS) device registration and listing, please see:
- Module for Initial Registration (Flash required)
- Instructions for Annual Registration (PDF-810KB)
The facility is required to pay the annual registration user fee using the Device Facility User Fee (DFUF) website before it can register and list a device. After paying the fee and obtaining the Payment Identification Number (PIN) and Payment Confirmation Number (PCN), the facility will need to complete registration and listing using the FURLS Device Registration and Listing Module (DRLM).
For the annual user fee amount, please see Device Registration and Listing.
Q: What happens if I list a device with a product code that differs from the device description?
A: It is incorrect to list a device with a product code that differs from the device description. If a device has been listed incorrectly and the appropriate product code is known, please deactivate your listing for the incorrect product code and create a new listing for the correct product code.
If you don’t know the correct product code, please use these educational resources: Device Advice: Classify Your Medical Device; or CDRH Learn Video: How is My Medical Device Classified? ; or search the Product Classification Database. If you need further assistance with determining the appropriate product code, please contact the Division of Industry and Consumer Education (DICE) at firstname.lastname@example.org for assistance.
Confirming Registration and Listing Information
Q: How do I obtain the FDA-assigned number that confirms my facility is registered with the FDA? Where do I find this information?
A: Receiving an assigned owner/operator number, registration number, or FDA Establishment Identifier (FEI) number verifies that your facility is registered.
This information is available on the Establishment Registration & Device Listing database after registration and listing are complete. To view or obtain the assigned numbers, type your facility’s name in the Establishment or Trade Name field of the database. If a registration number has been assigned, it will be visible in the Registration or FEI Number field. If a registration number has not yet been assigned, a facility-specific page will open instead. Selecting the facility name hyperlink on this page will open a new page displaying the owner/operator contact information and registration number.
If it has been less than 7 days since you have registered and listed your device, the official correspondent or owner/operator identified on the registration will need to use their Account ID and Password to log into the Online Account Administration site to locate the owner/operator and device listing information. The official correspondent or owner/operator should log in and select the DLRM option to access the DRLM Main Menu, where there is an option to select “View Your Registration and Listing Information.” Additional information is available by selecting “View Your Registered Facilities” or “View Your Device Listings.”
Q: How long does it take for a facility to receive its registration number once the registration process is complete?
A: It may take up to 90 calendar days for the FDA to assign a registration number to a facility. During this time, a facility can use its owner/operator number and device listing number (if applicable) to import its medical devices into the United States until the FDA assigns a registration number. After the FDA assigns a registration number, the FDA will send a confirmation email to the official correspondent informing them that a registration number has been assigned to the facility.
Q: Why is my facility not in the registration and listing database?
A: If a facility does not appear in the publicly available registration and listing database, the facility’s registration may be inactive or may have only recently been registered. The public registration and listing database is updated weekly.
Q: How does a purchaser verify registration and listing information?
A: If a facility has registered and listed, purchasers may verify the registration and listing status by entering the facility name in the search criteria using the Establishment Registration & Device Listing database. An assigned registration, FEI, or owner/operator number verifies that the facility is registered with the FDA. However, as explained in these FAQs, registration alone does not indicate that FDA has reviewed that facility’s device(s). Registration and listing may not be required for some facilities of authorized devices so purchasers may also verify whether specific medical devices have been authorized for use by referencing Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices.
Q: A facility is claiming to be “FDA Certified” by providing a third-party registration certificate. Does this mean the facility and the devices are certified by the FDA?
A: No. The FDA does not issue any type of device registration certificates to medical device facilities. When a facility registers and lists its devices, the resulting entry in FDA’s registration and listing database does not denote approval, clearance, or authorization of that facility or its medical devices.
Purchasers may verify registration status of a facility and the listing status for that facility’s medical devices by searching the Establishment Registration & Device Listing database, using the facility’s establishment name as the search criterion. Also, purchasers may verify the regulatory status of medical devices, unless the devices are exempt from premarket review, by searching the Premarket Notifications (510(k)s), De Novo, or Premarket Approvals (PMA) databases, using the device trade name as the search criterion.
Q: Does the FDA issue a license to import medical devices?
A: No. The FDA does not issue a license to import medical devices into the United States. The FDA requires importers that meet the definition of an initial importer found in 21 CFR Part 807.3(g) to register with the FDA. When a facility registers as an initial importer, it is required to pay the annual registration user fee using the Device Facility User Fee (DFUF) website. After paying the fee and obtaining the PIN and PCN, the facility can proceed to register using the FURLS and DRLM.
For step-by-step instructions on how to register and list your devices, see Device Registration and Listing page. For help with paying the annual registration user fee, please contact the User Fee Helpdesk at email@example.com. For additional assistance with completing initial registration, email the CDRH Registration and Listing Helpdesk at firstname.lastname@example.org.
Registration and Listing of Certain Medical Devices for Use Related to COVID-19
Q: I am an individual, health care organization, or state or municipal government in the United States who wishes to import masks or PPE such as gowns, respirators, and medical gloves into the United States, for my personal use or use in facilities under my control. Do I need to register and list?
A: If the individual, organization or other entity does not own or operate the facility that manufactures masks or PPE, registration and listing is generally not required.
However, if an individual, organization or other entity is importing and selling the masks or PPE, they are likely considered an initial importer and are required to register and list.
Additionally, an entity may be required to register and list as set forth in the device’s EUA. Devices authorized by FDA under an EUA that are imported should be declared as FDA-regulated with modified entry requirements as allowed by the EUA authorizing the device for emergency use. You must register and list if required by your device’s EUA letter of authorization.
For step-by-step instructions on how to pay the annual registration user fee and register a facility for the first time (initial registration), see Tutorials on the Device Registration and Listing page.