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 will no longer be in effect with the expiration of the COVID-19 PHE declaration on May 11, 2023, and guidances that the FDA is revising to continue in effect after the expiration of the PHE declaration.

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 fall 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 Emergency guidance, the FDA is implementing a 180-day transition period that will begin on the "implementation date." The implementation date is the date the COVID-19 section 319 PHE declaration expires or 45 days after the finalization of this guidance, whichever comes later. Because the COVID-19 section 319 PHE declaration is anticipated to expire at least 45 days after the finalization of this guidance, or May 11, 2023, the implementation date is that date (Phase 1 begins). For manufacturers that intend to continue to distribute devices after the relevant enforcement policies are no longer in effect, FDA recommends that manufacturers of devices that fall within the scope of the guidance register and list before the start of Phase 2, or by August 9, 2023 (Phase 2 begins). The guidances in List 1 will no longer be in effect after the 180-day transition period ends, or after November 7, 2023 (Phase 3 begins).

1. How do I import medical devices that fall within the enforcement policies in List 1 guidances during Phase 1 of the transition period?

Phase 1 begins on the implementation date, as specified in the guidance, which is May 11, 2023. For devices that fall within the enforcement policies in List 1 guidances, it is appropriate to transmit Intended Use Code (IUC) 081.006 (Enforcement discretion per final guidance) when filing an entry during Phase 1 of the transition period. During Phase 1 of the transition period, 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 that fall within the enforcement policies in List 1 guidances during Phase 2 of the transition period?

Phase 2 begins 90 days after the implementation date, as specified in the guidance, which is August 9, 2023. For devices that fall within the enforcement policies in List 1 guidances, it is appropriate to transmit Intended Use Code (IUC) 081.006 (Enforcement discretion per final guidance) and registration and listing when filing an entry during Phase 2 of the transition period. During the Phase 2 of the transition period, 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.

3. 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 importers to transmit 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.

4. 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 importers to transmit using 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.

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 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 importers 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 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. 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 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 Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency guidance, dated March 2023 (previous versions dated March, April, and May 2020, and September 2021) is intended to help expand the availability of particulate filtering facepiece respirators (including N95 respirators) for health care personnel related to COVID-19. The enforcement policy provides information about the regulatory landscape of certain 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? Do I need to register and list to import my PPE?

A: During the COVID-19 pandemic, the FDA worked to help facilitate the importation of FDA-regulated 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.  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. Registration, listing, and premarket approval or clearance file numbers may be optionally transmitted at the time of entry. The enforcement policy guidances 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.

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 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.

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 U.S., as well as situations where a modification to an FDA-cleared ventilator 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.

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. We recommend that you provide a copy of the signed EUA Letter of Authorization as part of your Import Entry documentation.

If your device is within the scope of the guidance Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency 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.

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.

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 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.

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. 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.

The FDA has issued a Policy for Coronavirus Disease-2019 Tests. 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.

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.