The FDA’s Center for Devices and Radiological Health issued two guidance documents to address the transition plans for device EUAs issued during the COVID-19 public health emergency (PHE). The first guidance is titled Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and the companion guidance document is titled Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 Public Health Emergency: Draft Guidance for Industry and Food and Drug Administration Staff.
The first guidance addresses planning transitions for devices that firms want to continue marketing after the PHE expires, as well as what firms that no longer wish to continue marketing of devices after the PHE expires must consider and do. This first guidance can be found here. Devices for which the EUA has already been withdrawn are not covered by this guidance.
The guidance outlines the requirements for early notifications by EUA holders to the Agency of their intentions regarding marketing, when to make submissions for continuation or changes to a device that will continue to be marketed, as well as how to deal with disposition of devices that firms no longer want to continue marketing. The guidance also provides examples of hypothetical timetables for various activities that will be required.
The second guidance addresses and expands transition planning by designating proposed timelines for three specific phases of activities that the FDA anticipates in the consideration of devices that have been issued EUAs during the PHE and the continuation or discontinuation of marketing for those products. This second guidance can be found here. It applies to devices that fall within the enforcement policies described in the list of guidances outlined in this document:
“As previously stated, FDA recognizes that it may take time for manufacturers, including non-traditional manufacturers of devices, to adapt and adjust their operations during the COVID-19 PHE back to normal operations. At this time, FDA does not intend to object to the continued distribution of devices within the scope of this guidance after the start of Phase 3 where:
- The manufacturer has submitted a marketing submission to FDA and had it accepted by FDA before the start of Phase 3; and
- FDA has not taken a final action on the marketing submission.”
Read together, these guidance documents provide significant insight as to how the FDA will handle post‑PHE activities related to devices that have EUAs, as well as the requirements and expectations that the Agency has of industry regarding products being marketing under EUAs and the transition to Agency approval or clearance. The Agency notes that these guidances are not for implementation currently and that it expects to receive comments on the guidance documents before finalization. Firms that are marketing medical devices or have marketed devices under an EUA must understand the proposed Agency requirements to ensure that they can meet the regulatory and quality requirements expected by the FDA once the PHE expires.