Importing Medical Devices Relating to COVID-19
November 8, 2023- The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023. The COVID-19 enforcement policy guidances within scope of the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.
The end of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act. The FDA encourages manufacturers of devices issued EUAs related to COVID-19 to review the guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19), which outlines the FDA's recommendations and expectations to such manufacturers to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?
On March 24, 2023, the FDA issued two final guidance documents regarding devices that fall within certain enforcement policies issued during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE) and devices issued Emergency Use Authorizations (EUAs) related to COVID-19 (the "COVID-19 Transition Plan guidances"). These guidances provide recommendations to manufacturers that may or may not want to continue to distribute medical devices after the guidances with those COVID-19 enforcement policies are no longer in effect or after the relevant EUA declaration related to COVID-19 terminates. This page provides information on importing medical devices that fell within certain COVID-19 enforcement policies or have been issued an EUA related to COVID-19. The website includes additional information to help prepare manufacturers, brokers, and other import stakeholders for the transition from policies adopted and operations implemented during the COVID-19 pandemic to normal operations. The website also provides examples and procedures related to importing medical devices during the transition period to illustrate the COVID-19 transition policies.
The information provided does not address products that are intended only for general, non-medical purposes (i.e., that are not medical devices), such as use in industrial or manufacturing settings, construction, or home improvement; for those products, importers do not need to transmit FDA-specific entry information.
The FDA has taken action to help expand availability of medical devices that might be of use in addressing the COVID-19 pandemic. Such medical devices generally fall into one of the following categories:
- Devices that fell within an enforcement policy in COVID-19-Related Guidance Documents. These guidance documents describe circumstances during which the FDA did not intend to object to certain device modifications, or the distribution and use of some types of devices, without compliance with certain regulatory requirements, as explained in each specific policy. When imported, these devices were declared as FDA-regulated with modified entry information specific to the enforcement policy.
- For more information on COVID-19-related guidances, 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.
- Devices that the FDA authorized under an EUA related to COVID-19. When imported, these devices should be declared as FDA-regulated with modified entry information per the EUA.
The FDA is providing information on importing certain medical devices during the transition period described in the COVID-19 Transition Plan guidances.
For more information regarding the COVID-19-related guidances that are not described in the COVID-19 Transition Plan guidances, please review the Guidance Documents Related to Coronavirus Disease 2019 (COVID-19) (88 FR 15417) notice published in the Federal Register on March 13, 2023. This notice provides information on guidances that are no longer in effect as of the expiration of the COVID-19 PHE declaration on May 11, 2023, guidances that are no longer in effect as of 180-days after that date (November 7, 2023), and guidances that the FDA has revised to continue in effect.
In particular, the below information relates to imports and registration and listing of devices within the scope of the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. The scope of this COVID-19 Transition Plan guidance is devices that fell within enforcement policies in certain guidances issued during the COVID-19 PHE (also referred to as the guidances in "List 1").
As described in the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergencyguidance, the FDA has implemented a 180-day transition period that began on the "implementation date." The implementation date was the date the COVID-19 section 319 PHE declaration expired or May 11, 2023. For manufacturers that intended to continue to distribute devices after the relevant enforcement policies were no longer in effect, FDA recommended that manufacturers of devices that fell within the scope of the guidance register and list before the start of Phase 2, or by August 9, 2023 (Phase 2 began). The guidances in List 1 are no longer in effect as of the end of the 180-day transition, or after November 7, 2023 (Phase 3 began).
1. How do I import medical devices that fall within the enforcement policies in List 1 guidances during Phase 3 of the transition period?
Phase 3 begins 180 days after the implementation date, as specified in the guidance, which is November 7, 2023. The guidances in List 1 will no longer be in effect after the 180-day transition period ends and Phase 3 begins, or after November 7, 2023.
For devices that fall within the enforcement policies in List 1 guidances, it is appropriate for filers to transmit the Intended Use Code (IUC)081.001: Standard import of a device, and an appropriate FDA product code. Under this IUC, the Affirmations of Compliance codes (AofC codes) for medical devices (such as the registration, listing, and premarket approval or clearance file numbers) can be submitted in the Automated Commercial Environment (ACE).
If the manufacturer has submitted a marketing submission to the FDA and it is accepted by the FDA before the start of Phase 3, a copy of the FDA Acceptance Review Notification can be transmitted to FDA via Import Trade Auxiliary Communication System (ITACS) to expedite initial screening and further review of your entry. If the FDA makes a negative decision on the marketing submission, manufacturers are expected to discontinue distribution, including importation, of the device.
2. I am a manufacturer of devices that fall within an enforcement policy in a List 1 guidance, and I received my marketing authorizations prior to the end of the transition period. How should I import my devices since I already have marketing authorization?
For medical devices that have marketing authorization prior to when the enforcement policies issued during the COVID-19 PHE are no longer in effect / before the end of the 180-day transition period (Phase 3), it is appropriate for filers to transmit the Intended Use Code (IUC) 081.001: Standard import of a device, and an appropriate FDA product code. Under this IUC, the Affirmations of Compliance codes (AofC codes) for medical devices (such as the registration, listing, and premarket approval or clearance file numbers) can be submitted in ACE.
3. How do I import COVID-19 medical devices that do not fall within the enforcement policies in List 1 guidances during Phase 3 of the transition period?
If your device is within the scope of a COVID-19 enforcement policy guidance for devices that are not identified in List 1 and referenced in Footnote 11, it is appropriate to monitor for updates to the respective guidances.For devices identified as subject to an active guidance, filers may transmit Intended Use Code (IUC) 081.006 (Enforcement Discretion per Final Guidance) when filing an entry. Registration, listing, and premarket approval or clearance file numbers may be optionally transmitted at the time of entry.
The FDA is also providing information related to imports and registration and listing of devices within the scope of the Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).
To facilitate the transition to normal operations for manufacturers that intend to continue to distribute devices after the relevant device EUA declaration has terminated, by the termination of the relevant device EUA declaration ("EUA termination date"), it is expected that manufacturers' registration and listing requirements are met for devices that fall within the scope of the Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).
1. How do I import medical devices issued EUAs prior to the termination of the relevant device EUA declaration?
For medical devices that have been issued an EUA, it is appropriate for filers to transmit the Intended Use Code (IUC) 940.000 (Compassionate Use/Emergency Use Device) when filing an entry. Prior to the termination of the relevant device EUA declaration, registration, listing, and premarket approval or clearance file numbers may be optionally transmitted at the time of entry. This information may also be included within the shipping documents to expedite initial screening and further review of your entry.
2. How do I import medical devices issued EUAs if the relevant device EUA declaration has terminated, but the marketing submission is still under review by the FDA?
For devices where the relevant EUA declaration has terminated, it is appropriate for filers to transmit theIntended Use Code (IUC) 081.001: Standard import of a device, and an appropriate FDA product code. Under this IUC, the Affirmations of Compliance codes (AofC codes) for medical devices (such as the registration, listing, and premarket approval or clearance file numbers if applicable) can be submitted in ACE.
If the manufacturer has submitted a marketing submission to the FDA and it is accepted by the FDA before the EUA termination date, a copy of the FDA Acceptance Review Notification can be transmitted to FDA via Import Trade Auxiliary Communication System (ITACS) to expedite initial screening and further review of your entry. Additionally, if the FDA makes a negative decision on the marketing submission, manufacturers are expected to discontinue distribution, including importation, of the device.
Q: How do I import NIOSH-approved respirators for use in health care settings by health care personnel?
A: To help avoid delays of legitimate shipments, importers are encouraged to review the Importing COVID-19 Supplies webpage.
The FDA intends to engage with importers to help minimize disruptions during the importing process. If you have any specific import questions related to COVID-19, you may email COVID19FDAIMPORTINQUIRIES@fda.hhs.gov.
Please note that the NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency EUA authorized the emergency use of NIOSH-approved respirators that appear on the NIOSH CEL list included in that EUA.
Q: Can I import respirators for use in health care settings by health care personnel that are not authorized/cleared by FDA?
A: Generally, respirators labeled as "respirators" intended for a medical purpose must be cleared or authorized by the FDA or approved by NIOSH and otherwise exempt from 510(k) requirements prior to importation.
Q: How do I import respirators for use as face masks?
A: The FDA's EUA for face masks describes the conditions under which face masks are authorized for emergency use. Respirators that are not authorized under an EUA, but meet the requirements for authorization set forth in the EUA for face masks (including labeling requirements) may be authorized under that EUA and imported as face masks.
Q: Can I import general purpose face masks?
A: Yes. Face masks intended for a general purpose -- that is, products that are not intended for a medical purpose such as preventing transmission of infection through respiratory secretions, and that are labeled only for general purposes such as industrial use -- may be imported. For face masks not intended for a medical purpose, entry information is not transmitted to the FDA; however, filers should continue to transmit entry information to U.S. Customs and Border Protection (CBP).
Q: I saw online that I can buy N95 respirators that are "FDA Certified" and include the FDA logo on the product box. Does the FDA certify N95 respirators?
A: No. The FDA does not certify products and the FDA logo is for the official use of the FDA and not for use on private sector materials. The FDA does not issue registration certificates to medical device facilities nor does the FDA certify information for facilities that have registered their establishments and listed their medical products. 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. See also, policy on use of the FDA logo.
Purchasers may verify the clearance or approval status of medical devices, unless exempt from premarket review, by searching the Premarket Notifications (510(k)s), De Novo, or Premarket Approvals (PMA) database, using the device trade name as the search criterion. You may also verify listing status for medical devices, including those exempt from premarket review, by searching the Establishment Registration & Device Listing database, using the establishment name as the search criterion. Purchasers may also verify whether specific products have been authorized for an emergency use related to COVID-19 by referencing the Emergency Use Authorizations for Medical Devices page.
Q: How do I import thermometers that are within the scope of the Enforcement Policy for Clinical Electronic Thermometers? Am I required to register and list?
A: The FDA issued an Enforcement Policy for Clinical Electronic Thermometers. If your device is within the scope of the guidance and the enforcement policy applies, it is appropriate for filers to transmit the Intended Use Code (IUC) 081.006 (Enforcement Discretion per Final Guidance), with the device product code when filing an entry. Registration, listing, and premarket approval or clearance file numbers may be optionally transmitted at the time of entry when using this IUC.
Q: How do I import tests or test kits for COVID-19? Am I required to register and list?
A: For devices that have been issued an EUA, it is appropriate for filers to transmit the Intended Use Code (IUC) 940.000 (Compassionate Use/Emergency Use Device) when filing an entry. Registration, listing, and premarket approval or clearance file numbers may be optionally transmitted at the time of entry when using this IUC. You must register and list if required by your device's EUA letter of authorization. We recommend that you provide a copy of the signed EUA Letter of Authorization as part of your Import Entry documentation.
Q: Who do I contact if I have a question about importing a device?
A: For questions regarding the regulatory requirements for the medical device being offered for import, please contact the CDRH Imports and Registration & Listing Team at: cdrhimport@fda.hhs.gov.
For assistance with general import procedures regarding personal protective equipment, test kits, or other products related to the public health emergency, please contact: COVID19FDAIMPORTINQUIRIES@fda.hhs.gov.
Inquiries related to a specific import entry are most appropriately routed to the FDA Import Division handling the entry.