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and foster compliance with applicable regulatory requirements when EUAs and COVID-19-related enforcement policies are no longer in effect.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. Read More→
https://content.govdelivery.com/bulletins/gd/USDHSCBP-35a3962?wgt_ref=USDHSCBP_WIDGET_2
