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CSMS # 58306521 - FDA Transition for Medical Devices Marketed Under EUA or an Enforcement Policy During the COVID-19 Pandemic
This message is an update to CSMS # 56244578 - FDA Transition Plan for Medical Devices Marketed Under EUA or an Enforcement Policy During the COVID-19 Pandemic, issued on May 12, 2023.
Enforcement Policy Devices included in List 1
Phase 3 of “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”(List 1) begins on November 7, 2023. As previously stated in CSMS #56244578 for medical devices that fall within List 1, the FDA is following a phased transition plan as outlined below:
- Phase 1: Began on the transition plan guidance implementation date, May 11, 2023. Manufacturers should currently be following 21 CFR Part 803 (i.e., adverse event reporting requirements).
- Phase 2: Began on August 9, 2023. Manufacturers should currently be following 21 CFR Part 806 (i.e., reports of corrections and removals requirements) and, if planned to continue to distribute their devices after the transition period, should also be following 21 CFR Part 807 Subparts B-D (i.e., registration and listing requirements).
- Phase 3 begins 180 days after the implementation date as specified in the guidance, which is November 7, 2023. The enforcement policies 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” will no longer be in effect after the 180-day transition period ends and Phase 3 begins, or after November 7, 2023. Manufacturers will be expected to comply with all statutory and regulatory requirements applicable to their devices as mentioned above and including, 21 CFR Part 801 Subpart B, and 21 CFR Part 830, except as discussed below regarding marketing submissions.
- 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 by FDA if the manufacturer intends to continue distribution of the device after the enforcement policies in List 1 are no longer in effect.
- FDA does not intend to object to continued distribution of devices within the scope of the 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 Phase 3, at the time of entry, for devices listed in List 1, filers 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 approval or clearance file numbers) can be submitted via 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, you may transmit the marketing submission number under FDA review. 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.
FDA expects manufacturers to discontinue distribution of a device within the scope of this guidance on the date the manufacturer receives a negative decision on its marketing submission as FDA’s final action, or on the date the manufacturer withdraws its submission or fails to provide a complete response to an FDA request for additional information within the allotted time identified in FDA’s letter.
Enforcement Policy Devices listed in footnote 11
The following enforcement policies identified in footnote 11 are not covered by the transition plan phased approach:
For the devices that meet the requirements of the above active (not expired) enforcement policies (listed in footnote 11) at the time of entry, it is appropriate for filers 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 via ACE.
Emergency Use Authorization (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 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.
Once an EUA is terminated, for medical devices that have a marketing submission submitted and accepted by FDA, filers 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 approval or clearance file numbers when applicable) should be submitted via ACE.
If the manufacturer has submitted a marketing submission to the FDA and it is accepted by the FDA before the EUA termination date and FDA has not taken a final action on the marketing submission, you may transmit the marketing submission number under FDA review. 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.
FDA expects manufacturers to discontinue distribution of a device within the scope of this guidance on the date the manufacturer receives a negative decision on its marketing submission as FDA’s final action, or on the date the manufacturer withdraws its submission or fails to provide a complete response to an FDA request for additional information within the allotted time identified in FDA’s letter.
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: 42124872, 42168200, 56244578
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