Importing Medical Devices During the COVID-19 Pandemic

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The Food and Drug Administration (FDA) continues critical work to protect public health, including the review of shipments of medical devices offered for import during the COVID-19 pandemic. This page provides information on importing certain medical devices during the COVID-19 pandemic. It describes procedures for importing devices that have been issued Emergency Use Authorizations (EUA) and for devices for which an enforcement discretion policy has been published in guidance. It does not address products that are intended only for general, non-medical purposes, such as use in industrial or manufacturing settings, or 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 may be of use during the COVID-19 pandemic. Such medical devices generally fall into one of the following categories:

  • Devices for which the FDA has issued a device-specific enforcement policy in COVID-19-Related Guidance Documents. When imported, these devices should be declared as FDA-regulated with modified entry information specific to the enforcement policy. These guidance documents describe circumstances during which the FDA does 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.
  • Devices that the FDA has authorized for emergency use. When imported, these devices should be declared as FDA-regulated with modified entry information per the EUA.

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Importing Respirators, Face Masks, and Other PPE

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. Importers are also encouraged to review the webpage with Information for Filing Personal Protective Equipment and Medical Devices During COVID-19, which includes instructions for submission of entry information for personal protective equipment and certain devices as well as other information.

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" emergency use authorization (EUA) authorized the emergency use of NIOSH-approved respirators that appear on the NIOSH CEL list included in that EUA.

The Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance dated May 2020 is intended to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care personnel for the duration of the COVID-19 public health emergency. The Enforcement Policy provides information about the regulatory landscape of certain face masks, surgical masks, and respirators, which may be useful for importers.

Q: Can I import respirators for use in health care settings by health care personnel that are not authorized under an EUA?

A : No. Generally, respirators labeled as "respirators" intended for a medical purpose must be cleared or authorized by the FDA or approved by NIOSH 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, importers/filers should continue to transmit entry information to U.S. Customs and Border Protection (CBP).

Q: How can I import personal protective equipment (PPE), other than surgical masks or respirators, for use during the COVID-19 pandemic? Do I need to register and list to import my PPE?

A: During the COVID-19 pandemic, the FDA is working to help facilitate the importation of FDA-regulated Personal Protective Equipment (PPE) into the United States. Please see the applicable PPE EUAs, listed on the Emergency Use Authorizations for Medical Devices webpage, for example, Face Shields. Additionally, the FDA has issued several enforcement policy guidances, listed on the COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders webpage, for example, Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency.

  • Medical Devices Authorized For Emergency Use
    For devices that have been issued an EUA, it is appropriate to transmit the Intended Use Code (IUC) 940.000 (Compassionate Use/Emergency Use Device) when filing an entry. During the COVID-19 Public Health Emergency, registration, listing and premarket approval or clearance file numbers may be optionally transmitted at the time of entry. You must register and list if required by your device's EUA letter of authorization.
  • Medical Devices within the Scope of an Enforcement Policy Guidance
    If your device is within the scope of an enforcement policy guidance and the enforcement policy applies, it is appropriate to transmit the Intended Use Code (IUC) 081.006 (Enforcement Discretion per Final Guidance) when filing an entry. During the COVID-19 Public Health Emergency, registration, listing and premarket approval or clearance file numbers may be optionally transmitted at the time of entry. These guidance documents describe circumstances during which the FDA does 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. For some of these policies, these regulatory requirements include registration and listing.

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 emergency use during the COVID-19 emergency by referencing the Emergency Use Authorizations page.

Importing Other Medical Devices

Q: How do I import into the U.S. sterilizers, disinfectant devices, and air purifiers that are within the scope of FDA's enforcement policy guidance? Am I required to register and list?

A: The FDA issued an Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease (COVID-19) Public Health Emergency that describes the policy for these devices. If your device is within the scope of the guidance and the enforcement policy applies, it is appropriate to transmit the 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 when using this IUC. The enforcement policy describes the circumstances during which the FDA does not intend to object to certain modifications to, or the distribution and use of, devices within the scope of the guidance without compliance with certain regulatory requirements, including registration and listing.

Q: How do I import ventilators that have been issued an Emergency Use Authorization (EUA)? Am I required to register and list?

A: The FDA issued an Emergency Use Authorization for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories. This EUA addresses devices that are not currently marketed in the United States as well as situations where a modification to an FDA-cleared ventilator that does not fall within the scope of the Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. We recommend that you also provide a copy of the signed EUA Letter of Authorization as part of your Import Entry documentation.

If your ventilator, ventilator tubing connector, or ventilator accessory is listed in Appendix B of the EUA it is appropriate 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.

Additionally, the FDA issued an Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. If your device is within the scope of the guidance and the enforcement policy applies, it is appropriate to transmit the 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 when using this IUC.

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 During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. If your device is within the scope of the guidance and the enforcement policy applies, it is appropriate to transmit the Intended Use Code (IUC) 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. The enforcement policy describes the circumstances during which the FDA does not intend to object to the distribution and use of devices within the scope of the guidance without compliance with certain regulatory requirements, including registration and listing.

Q: How do I import ophthalmic devices that are within the scope of the Enforcement Policy for Remote Ophthalmic Assessment and Monitoring devices?

A: The FDA issued an Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices. If your device is within the scope of the guidance and the enforcement policy applies, it is appropriate to transmit the Intended Use Code (IUC) 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 infusion pumps that are within the scope of the Enforcement Policy for Infusion Pumps and Accessories?

A: The FDA has issued an Enforcement Policy for Infusion Pumps and Accessories. If your product is within the scope of the guidance and the enforcement policy applies, it is appropriate to transmit the Intended Use Code (IUC) 081.006 (Enforcement Discretion per Final Guidance) with the relevant device product code. Registration, listing, and premarket approval or clearance file numbers may be optionally transmitted at the time of entry when using this IUC. The enforcement policy describes the circumstances during which the FDA does not intend to object to the distribution and use of devices within the scope of the guidance without compliance with certain regulatory requirements, including registration and listing.

Manufacturers of devices not already approved or cleared for use in the United States may request emergency use authorization as outlined in the guidance. For infusion pumps with an EUA, please see Information for Filing Personal Protective Equipment and Medical Devices During COVID-19. For questions about the EUA process, contact CDRH-COVID19-InfusionPumps@fda.hhs.gov.

Q: How do I import extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices and accessories that have been issued an EUA or are within the scope of the Enforcement Policy for ECMO and Cardiopulmonary Bypass Devices?

A: For devices that have been issued an EUA, it is appropriate for importers to transmit the Intended Use Code (IUC) 940.000 (Compassionate Use/Emergency Use) when filing an entry. The EUA list can be found on the Emergency Use Authorizations for Medical Devices webpage. 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 also provide a copy of the signed EUA Letter of Authorization as part of your Import Entry documentation.

The FDA has issued an Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. If your product is within the scope of the guidance and the enforcement policy applies, it is appropriate for importers to transmit the Intended Use Code (IUC) 081.006 (Enforcement Discretion per Final Guidance) and the FDA 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. This policy does not address registration and listing requirements.

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 importers to transmit the Intended Use Code (IUC) 940.000 (Compassionate Use/Emergency Use Device) when filing an entry. We recommend that you also provide a copy of the signed EUA Letter of Authorization as part of your Import Entry documentation. 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.

The FDA has issued a Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. If your product is within the scope of the guidance and one of the policies within the guidance applies, it is appropriate for importers to 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 when using this IUC.

Checking Import Status and Contact for Import Questions

Q: How do I check the status of my imported devices?

A: If you are importing a product that's regulated by the FDA, you can check the status of the shipment by using the Import Trade Auxiliary Communications System (ITACS) portal or by contacting the local FDA office where your product is being imported.

It is important to provide your entry number to allow for FDA follow-up. Additionally, to assist with the entry review process, we recommend that you also provide a copy of the signed EUA Letter of Authorization as part of your Import Entry documentation at the time of entry submission. Also see the FDA's ITACS web page for more information.

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.