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CSMS # 56244578 - FDA Transition Plan for Medical Devices Marketed Under EUA or an Enforcement Policy During the COVID-19 Pandemic

On 3/24/2023, the FDA posted the “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” and “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”

These guidance documents will help prepare manufacturers and other stakeholders for the transition to normal operations and foster compliance with applicable regulatory requirements when EUAs and COVID-19-related enforcement policies are no longer in effect. 

EUA Devices

As stated in the “Transition Plan for Medical Devices Issued Emergency Use Authorizations During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” FDA does not intend to object to the continued distribution of devices within the scope of the guidance during the transition period.

For medical devices that have been issued an EUA and the EUA has not been terminated, it is appropriate to continue to transmit the Intended Use Code (IUC) 940.000: Compassionate Use/Emergency Use Device when filing an entry. During the transition period and prior to the respective EUA’s termination date, registration, listing and premarket approval or clearance submission 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.

Once an EUA is terminated, for medical devices that have a pre-market submission submitted and accepted by FDA, importers should 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 numbers) should be submitted in the Automated Commercial Environment (ACE). You may transmit your 510(k) number for the pre-market submission under FDA review and upload a copy into the Import Trade Auxiliary Communications System (ITACS) of the notification indicating that your submission has been accepted.

Enforcement Policy Devices

Additionally, the FDA does not intend to immediately withdraw the enforcement policy guidances identified in List 1 of the “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” guidance document but rather intends to follow a phased transition plan as outlined below:

• Phase 1: Begins on the implementation date, May 11, 2023. Manufacturers should follow 21 CFR Part 803 (i.e., adverse event reporting requirements).
• Phase 2: Begins 90 days after the implementation date, August 9, 2023. Before the start of Phase 2, manufacturers should follow 21 CFR Part 806 (i.e., reports of corrections and removals requirements) and, if planning to continue to distribute their devices after the transition period, should also follow 21 CFR Part 807 Subparts B-D (i.e., registration and listing requirements).
• Phase 3: Begins 180 days after the implementation date, November 7, 2023. At the start of Phase 3, FDA intends to withdraw the enforcement policy guidances in List 1 and manufacturers will be expected to comply with all statutory and regulatory requirements applicable to their devices (e.g., 21 CFR Part 820, 21 CFR Part 801 Subpart B, and 21 CFR Part 830), except as discussed below regarding premarket authorization.
  • Prior to the start of Phase 3 (before November 7, 2023), FDA expects any marketing submission for a device within the scope of the transition plan guidance to be submitted and accepted if the manufacturer intends to continue distribution of the device after the enforcement policy guidances in List 1 are withdrawn.
  • FDA does not intend to object to continued distribution of devices within the scope of the enforcement policy transition plan guidance where a marketing submission has been submitted and accepted by FDA before the start of Phase 3 and FDA has not taken a final action on the marketing submission.

During Phases 1 and 2, for devices that meet the applicable enforcement policy at the time of entry, importers should transmit Intended Use Code 081.006: Enforcement discretion per final guidance, and an appropriate FDA product code.  Under this Intended Use Code, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) may be optionally transmitted in ACE. 

During Phase 3, at the time of entry, importers should 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 numbers) should be submitted in ACE. You may transmit your 510(k) number for the pre-market submission under FDA review and upload a copy into ITACS of the notification indicating your submission has been accepted.

For more information on importing medical devices relating to COVID-19 visit: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/importing-medical-devices-relating-covid-19.

For questions regarding the transition plan guidance documents, please contact CDRH’s Regulation, Policy, and Guidance Staff at RPG@fda.hhs.gov.

For questions regarding the regulatory requirements of 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. For more information refer to: Import Offices and Ports of Entry | FDA.

For general import inquiries, contact: Imports@fda.hhs.gov.

Related messages: CSMS #42124872, #42168200