Transitioning US COVID-19 EUA Devices after EUA Termination

On March 24, 2023, the US Food and Drug Administration finalized two guidance documents: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). These guidance documents outline the FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations. 

First, it is important to clarify the two ways in which FDA implemented enforcement discretion for their policies and devices as part of the COVID-19 pandemic. One way was through declaration of a PHE in accordance with section 319 of the Public Health Service Act (PHS Act) that allowed FDA to update enforcement policies related to how they regulate devices under the emergency. For COVID-19, this led to the issuance of multiple guidance documents that described changes in FDA enforcement related to specific devices and services. The transition plan for these is discussed in the new Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. The second way FDA implemented enforcement discretion as part of the COVID-19 pandemic was by EUA declaration under section 564 of the FD&C Act, which allowed FDA to make case-by-case decisions to authorize select devices under emergency use related to the specific COVID-19 emergency. It is important to note that an EUA declaration under section 564 of the FD&C Act is distinct from, and is not dependent on, a declaration by the HHS Secretary of a PHE under section 319 of the PHS Act. As such, the device EUAs related to COVID-19 remain in effect until the relevant EUA declaration under section 564 of the FD&C Act is terminated or FDA otherwise revokes a specific EUA, even if the section 319 PHE declaration related to COVID-19 expires before then. The transition plan for devices authorized under EUA is outlined in the second guidance, Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). Since the latter guidance is most relevant to IVD devices, let’s look more closely at what FDA expects from manufacturers of devices authorized under EUA.

Manufacturers of IVD devices authorized under EUA will have three options to move forward once the FDA announces a termination date for:

• Seek FDA approval/clearance for their IVD device
• Continue to distribute their IVD authorized under EUA until the EUA termination date after which time they cease distribution
• Discontinue distribution of their IVD authorized under EUA immediately

Manufacturers seeking FDA approval/clearance for their IVD devices authorized under EUA

Manufacturers of devices authorized under an EUA seeking the required marketing authorization for their devices should submit their marketing submissions (e.g., 510(k), PMA, De Novo, etc.) to FDA with sufficient time for the submission to be accepted by FDA before the to be published EUA termination date. The marketing submission should reference previous EUAs in the cover letter and be administratively complete in that it includes all the information necessary for FDA to conduct a substantive review (i.e., the content of the submission should meet the requirements of the appropriate submission guidance and/or the acceptance checklist outlined in FDA’s refuse to accept policy).

FDA reminds manufacturers that use of their devices during the COVID-19 pandemic may produce a variety of data sources useful for their marketing submission. Manufacturers looking to reference data from related marketing authorizations and submissions and use real-world data obtained as a result of device use during the COVID-19 pandemic should consult FDA guidance Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.

FDA acknowledges that some manufacturers may wish to include changes or updates to the device and/or its labeling compared to the product that has been distributed under the EUA. For these, FDA emphasizes that in some cases, a manufacturer may not receive a positive decision from FDA. As such, when manufacturers submit their marketing submission, they should include in the cover letter a “Transition Implementation Plan” that addresses the manufacturers’ plans for dealing with devices already distributed in the case of a positive decision as well as in the case of a negative decision on the marketing submission. The Transition Implementation Plan should include the following information, as applicable:

• Estimated number of devices under an EUA that are currently in US distribution;
• In the event of a negative decision, an explanation of the manufacturer’s benefit-risk based plan for disposition of already distributed product. If the manufacturer is proposing to leave already distributed product in place, the plan should address the rationale for doing so and considerations such as the following, where relevant:
  • Process for notifying patients, consumers, healthcare facilities, healthcare providers, and device distributors of the device’s regulatory status;
  • Process and timeline for restoring already distributed devices to an FDA-cleared or -approved version;
  • Process and timeline for providing a physical and/or electronic copy of updated labeling that accurately describes the product features and regulatory status (e.g., that the product lacks FDA clearance, approval, or authorization) for reusable devices; and
  • A description of the maintenance plan for already distributed devices.
• In the event of a positive decision, an explanation of the manufacturer’s plans for addressing already distributed product, including considerations such as the following, where relevant:
  • Process for notifying patients, consumers, healthcare facilities, healthcare providers, and device distributors of the device’s regulatory status; and
  • Process and timeline for providing to users of already distributed devices updated labeling or components for the cleared or approved device, including updated labeling or components to reflect any cleared/approved changes to the already distributed device.

Enforcement policy for devices with a marketing submission under review by FDA

FDA does not intend to object to the continued distribution of devices authorized under an EUA after the EUA termination date where:

• The manufacturer has submitted a marketing submission[1] to FDA and it is accepted[2] by FDA before the EUA termination date; and
• FDA has not taken a final action on the marketing submission.

For these same devices, while the device is under FDA review, FDA does not intend to object to the devices not bearing a Unique Device Identification (UDI)[3] or complying with other applicable labeling requirements[4] where the device continues to be labeled as previously authorized under the EUA. 

FDA emphasizes that this enforcement policy only relates to FDA marketing authorization (e.g., 510(k) clearance), UDI, and certain labeling requirements. It does not apply to other legal requirements such as registration and listing, quality system, reports of corrections and removals[5] that may apply after the EUA termination date. FDA also makes clear that this enforcement policy does not apply after FDA has taken final action on the device’s marketing submission. At that time, FDA expects manufacturers to comply with all applicable regulatory requirements for the device/manufacturer, including labeling updates⁴, compliance with UDI requirements³, and any applicable updates to registration and listing information, including the submission number[6]. After marketing authorization, manufacturers also should follow the steps outlined in their Transition Implementation Plan.

For IVDs authorized under an EUA for use in high complexity, moderate complexity, and waived settings where, the manufacturer has submitted a marketing submission to FDA and it is accepted by FDA before the EUA termination date, and FDA has not taken a final action on the marketing submission or made a determination on CLIA categorization, FDA does not intend to object to the continued distribution and use of such tests consistent with the requirements described here and in a manner consistent with the EUA that was in effect prior to the EUA termination date.

Additional considerations for EUA-authorized in vitro diagnostics – Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization and waivers

In short, the CLIA status given to a particular EUA-authorized IVD only applies to the EUA-authorized device up to the EUA termination date. Manufacturers should not assume that the CLIA status their IVD device had under EUA will prevail. FDA will categorize the test’s complexity immediately following FDA’s final action on the marketing submission, per FDA’s typical categorization process, which may render a different conclusion.

For IVDs authorized under an EUA for use in patient care settings operating under a CLIA Certificate of Waiver, FDA intends to accept marketing submissions under their Dual 510(k) and CLIA Waiver by Application pathway, or Dual De Novo and CLIA Waiver marketing submissions modeled after the 510(k) and CLIA Waiver by Application pathway, as appropriate. As recommended in FDA’s guidance Recommendations for Dual 510(k) and CLIA Waiver by Application Studies, manufacturers interested in this pathway should first submit a Pre-Submission to notify FDA of the plan to submit a dual application and to discuss planned study designs for comparison and reproducibility studies that support the marketing submission and the CLIA waiver. Manufacturers are reminded that data regarding actual use of the IVDs in CLIA-waived settings, including use of the IVD under the EUA, for comparison and reproducibility studies will be helpful in making a CLIA waiver determination. Manufacturers of such tests are requested to prioritize their marketing submissions to facilitate FDA’s review and CLIA categorization prior to EUA termination to reduce the potential for disruption in distribution and use.

For IVDs authorized under an EUA for home use, if a marketing submission for such test is subsequently cleared, approved, or authorized for home use, the test will be waived by regulation under 42 CFR 493.15(c), meaning that the test will be categorized as waived without the need for a CLIA Waiver by Application.

Manufacturers continuing to distribute their IVD authorized under EUA only until the EUA termination date

When a manufacturer does not intend to continue to distribute its device beyond the EUA termination date, FDA does not intend to object to the disposition and use of already distributed devices (i.e., FDA does not intend to request market removal) as follows:

• Single-use, non-life-supporting/non-life-sustaining devices (e.g., face masks), including IVDs, that were distributed before the EUA termination date are used by the end user prior to the product expiration date, as applicable.
  • NOTE: For IVDs that were authorized under EUA, this is the product expiration date listed as of the EUA termination date. Extension of the expiration date cannot be authorized after the EUA is terminated.
• Reusable, non-life-supporting/non-life-sustaining devices (e.g., non-invasive remote patient monitoring devices) that were distributed before the EUA termination date are used by their end user and either: 
  • Are restored by the manufacturer to an FDA-cleared or -approved version of the device, or 
  • Have a physical and/or electronic copy of updated labeling that accurately describes the product features and regulatory status (e.g., that the product lacks FDA clearance, approval, or authorization). 

• Reusable life-supporting/life-sustaining devices (e.g., ventilators, extracorporeal membrane oxygenation systems, continuous renal replacement therapy systems) that were distributed before the EUA termination date are restored by the manufacturer to an FDA-cleared or -approved version of the device so that they may be used by their end user. If not restored, a physical and/or electronic copy of updated labeling that accurately describes the product features and regulatory status (e.g., that the product lacks FDA clearance, approval, or authorization) should be provided, and such devices are not to be used. To help ensure accessibility to updated labeling, FDA recommends that stakeholders be provided an opportunity to request a physical copy of updated labeling, and after such request, be provided the requested labeling without additional cost.

Manufacturers should be aware of any applicable legal requirements for their device, such as adverse event reporting under 21 CFR Part 803, and are expected to comply with such requirements for the duration in which they are applicable, which may extend beyond the cessation of distribution.

For IVDs authorized under an EUA for use in high complexity, moderate complexity, and waived settings that were already distributed before the EUA termination date, FDA does not intend to object to the continued use of such tests prior to the product expiration date in a manner consistent with the EUA that was in effect prior to the EUA termination date.

Discontinuing distribution of a device

 Manufacturers may voluntarily withdraw their devices from the market. For manufacturers that do not intend to continue distributing their devices and that intend to voluntarily withdraw their devices from the market, withdrawal of the devices from the market should be completed prior to the EUA termination date; otherwise, if withdrawal of the devices from the market is not completed prior to the EUA termination date, FDA recommends restoring and/or updating labeling for reusable non-life-supporting/non-life-sustaining devices and for reusable life-supporting/life-sustaining devices as outlined above prior to the EUA termination date. Manufacturers should be aware of any applicable legal requirements for their device, such as adverse event reporting under 21 CFR Part 803, and continue to comply with such requirements for the duration in which they are applicable, which may extend beyond the cessation of distribution or withdrawal.

FDA expects manufacturers to discontinue distribution of a device authorized under an EUA:

• On the EUA termination date, if the manufacturer has not submitted a required marketing submission for its device and had it accepted by FDA before the EUA termination date; or
• 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.

In addition, manufacturers should be aware of any applicable legal requirements for their device, such as adverse event reporting under 21 CFR Part 803, and continue to comply with such requirements for the duration in which they are applicable, which may extend beyond the cessation of distribution.

Laboratory developed tests (LDTs)

FDA has generally exercised enforcement discretion for laboratory developed tests (LDTs), meaning that FDA generally does not exercise its authority to enforce the regulatory requirements for these devices, although it maintains that authority. FDA has not applied this general enforcement discretion approach to, among other LDTs, those used for declared emergencies under section 564 of the FD&C Act. As such, following termination of the EUA declaration for COVID-19 IVDs, FDA intends to have the same  enforcement approach for COVID-19 LDTs as it does for other LDTs.

Example scenarios

FDA concludes the transition guidance with multiple example scenarios to help manufacturers navigate their options. Because no EUA termination date has yet been set, FDA uses in their examples the hypothetical advance notice of termination date for the EUA declaration pertaining to the device at issue as July 1 in Year 1, and the EUA termination date as January 1 in Year 2. FDA emphasizes that this date is not intended to propose an actual advance notice of termination or EUA termination date and is hypothetical and for illustrative purposes only.

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[6] See 21 CFR Part 807 Subparts B-D