This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1) Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (the “Enforcement Policy Transition Guidance”) and 2) Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) (the “EUA Transition Guidance”), both dated March 27, 2023. These final guidance documents finalize the corresponding draft guidances issued on December 23, 2021, and both set out a 180-day transition period.
Enforcement Policy Transition Guidance
The 180-day transition period under the Enforcement Policy Transition Guidance will start on the “implementation date,” which will be May 11, 2023, unless the PHE declaration is renewed another time contrary to the Administration’s current plan. The Enforcement Policy Transition Guidance applies to devices that fall under 15 FDA COVID-19 enforcement policies, where FDA has indicated that it does not intend to object to certain modifications or distribution of certain devices in the following categories:
- remote digital pathology devices;
- imaging systems;
- non-invasive fetal and maternal monitoring devices;
- telethermographic systems;
- digital health devices for treating psychiatric disorders;
- extracorporeal membrane oxygenation and cardiopulmonary bypass devices;
- remote ophthalmic assessment and monitoring devices;
- infusion pumps and accessories;
- face shields, surgical masks, and respirators;
- gowns, other apparel, and gloves;
- sterilizers, disinfectant devices, and air purifiers;
- ventilators and accessories and other respiratory devices;
- FDA-cleared molecular influenza and RSV tests;
- coagulation systems; and
- viral transport media.
These policies are all currently set to expire on November 7, 2023, which is 180 days after May 11, 2023.
The Enforcement Policy Transition Guidance sets out three phases: Phase 1 (first 90 days after the implementation date—expected to be from May 11 to August 8, 2023); Phase 2 (the second 90 days after the implementation date—expected to be from August 9 to November 6, 2023); and Phase 3 (180 days after the implementation date—expected to begin on November 7, 2023). In the Enforcement Policy Transition Guidance, FDA provides phase‑by‑phase compliance guidance for manufacturers of a device that falls under any of the FDA COVID-19 enforcement policies mentioned above. It is important to note that some of the guidance applies to manufacturers regardless of whether they intend to continue distribution of the device after a certain phase. For example, manufacturers should send a notification of intent to FDA regardless of whether they intend to continue distribution of their device after Phase 2.
EUA Transition Guidance
The 180-day transition period under the EUA Transition Guidance, on the other hand, will start when the corresponding EUA declaration terminates (the “EUA termination date”). The EUA Transition Guidance applies to devices that are authorized under any of the EUA declarations related to COVID-19 such as the EUA declaration for COVID-19 in vitro diagnostics (the “EUA devices”). As FDA explains in the guidance, an EUA declaration is not dependent on the PHE declaration, which means that the 180-day transition period for the EUA devices may start well after the PHE declaration expires, that is, possibly well after May 11, 2023.
The EUA Transition Guidance requests manufacturers of the EUA devices that FDA deems to be “reusable life-supporting or life-sustaining” to submit a letter of intent to FDA as soon as possible, regardless of their intent to continue distribution of the device after the EUA termination date. Note that this request is effective as of March 27, 2023, and manufacturers should not wait until the transition period or the EUA termination date to submit the intent letter. Section A of the guidance provides the details including the product codes relevant to this request and the information to include in the letter.
The EUA Transition Guidance also provides recommendations and policies for manufacturers seeking a full marketing authorization for a device related to any of their EUA devices. The guidance indicates that FDA does not intend to object to continued distribution of the EUA device after the EUA termination date, if (i) the manufacturer submits a marketing submission for a candidate device that is the same as, derivative of, or next generation of the EUA device, (ii) FDA formally accepts the marketing submission before the EUA termination date, and (iii) FDA has not taken a final action on the marketing submission. Since FDA’s formal acceptance of the marketing submission could be delayed due to various reasons, including administrative incompleteness of the submission, manufacturers are advised to submit well before the EUA termination date.
Flexibilities
Notably, both guidance documents indicate FDA’s willingness to be flexible in certain areas. For example, the guidance documents indicate that real-world data from the actual use of the device during the COVID-19 pandemic may be included in the marketing submission. Both guidance documents also recommend manufacturers to engage with FDA early in the transition period to discuss extenuating circumstances such as an ongoing clinical study that makes it difficult to meet certain deadlines provided in the guidance. Further, both guidance documents acknowledge that there may be unique quality system compliance considerations for certain manufacturers and suggest requesting an exemption or variance from a device quality system requirement within the first 90 days of each transition period.
Finalization of these guidances does not necessarily mean that the COVID-19 EUA declarations will be terminated soon or that FDA will soon cease accepting and reviewing new EUA requests. At the same time, however, it certainly gets us closer to such transitions. This is an important development, and manufacturers who have distributed devices under an EUA or under one of these enforcement discretion policies during the pandemic should seek the advice of counsel to ensure compliance with the transition.