Key Takeaways:

• The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents.
• The Transition Plan for EUA-Authorized Devices will allow continued marketing and use of such devices during the FDA’s review of premarket submissions.
• The Transition Plan for COVID-19-Related Device Policies will implement a phased return to pre-pandemic regulation for many devices.  

On January 31, 2020, in response to the COVID-19 pandemic, the Secretary of Health and Human Services (HHS) issued a declaration of a public health emergency (PHE) under Section 319 of the Public Health Service Act (PHS Act). A Section 319 PHE authorizes the Secretary to take various discretionary actions, such as making grants, entering into contracts, and conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder, in response to the PHE.

Following this declaration, the Secretary determined pursuant to his authority under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that circumstances existed that justified the authorization for the emergency use of unapproved medical products or unapproved uses of approved medical products to address the effects of the SARS-CoV-2 virus. The Secretary subsequently issued EUA declarations for various medical products, including for in vitro diagnostics and other medical devices.

The FDA has invoked these authorities throughout the PHE. Pursuant to its authority under the Section 319 PHE, the FDA issued a number of enforcement discretion policies to facilitate the availability of devices to support the emergency response to the pandemic and expand the availability and remote monitoring capabilities of certain devices. In accordance with its authority established by the EUA declarations issued pursuant to the Section 564 PHE, the FDA issued EUAs for medical devices used in diagnosing, treating, and stemming the spread of COVID-19.

With the worst of the pandemic behind us, the COVID-19 Section 319 PHE declaration is set to expire on May 11, 2023. An EUA declaration made under Section 564 of the FD&C Act, however, is separate from, and not dependent on, a Section 319 PHE declaration. An EUA declaration issued under Section 564 of the FD&C Act remains in effect until terminated by the Secretary. An EUA issued under Section 564 remains in effect for the duration of the relevant EUA declaration unless the FDA chooses to revoke that EUA when the criteria for issuance are no longer met or to protect the public health or safety.

On Friday, March 24, 2023, the FDA finalized two guidance documents, Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) (“EUA Transition Plan Guidance”), and Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (“Enforcement Policy Transition Plan Guidance”), to describe how manufacturers can ensure continued availability of devices granted EUAs and the FDA’s plans for a phased sunsetting of enforcement policies implemented for medical devices during the PHE.

EUA Transition Plan Guidance

As explained above, an EUA can remain in effect even after the Section 319 PHE declaration has expired, so long as the relevant EUA declaration under Section 564 of the FD&C Act is still in effect and other statutory requirements are met. The Secretary is required to issue an advance notice in the Federal Register before terminating an EUA declaration, and the termination of an EUA declaration will signify the termination of all EUAs issued based on that declaration, with exceptions for specific circumstances. The EUA Transition Plan Guidance announced the FDA’s intent to publish advance notice in the Federal Register 180 days before the termination date of each EUA declaration pertaining to devices. During the time between the advance notice of termination of an EUA declaration and the EUA termination date, a manufacturer of a device with an EUA issued pursuant to that EUA declaration must continue to comply with the terms of the device’s specific EUA, including applicable conditions of authorization identified in the EUA letter of authorization.

General Policy. Following publication of an advance notice of termination of an EUA declaration, the FDA recommends that manufacturers of affected devices submit a premarket submission (i.e., a 510(k) premarket notification, premarket approval (PMA) application, or petition for de novo review) to the FDA. The FDA recommends manufacturers include a Transition Implementation Plan in their submissions to address plans for devices already in distribution following the FDA’s decision on the marketing application.

Provided the FDA completes its acceptance review before the EUA declaration termination date, the FDA plans to exercise enforcement discretion—that is, it will allow continued marketing of the device during the FDA’s review of the premarket submission. The scope of enforcement discretion extends to the FDA marketing authorization, unique device identifier (UDI), and certain labeling requirements, but not to other legal requirements (e.g., registration and listing, and Quality System Regulations) after the EUA declaration terminates.

The EUA Transition Plan Guidance also provides the FDA’s policy concerning EUA-authorized devices in distribution for which there is no plan to submit a premarket submission to the FDA. The FDA will not object to the continued use of such devices as follows: 
 

(i)  Single-use, non-life-supporting/non-life-sustaining devices may continue to be used by the end user prior to the product expiration date.
 

(ii)  Reusable, non-life-supporting/non-life-sustaining devices may continue to be used by the end user provided they are either restored to an FDA-cleared or approved version of the device or have updated and accurate labeling (including indicating that the product lacks FDA clearance, approval, or authorization).
 

(iii)  Reusable life-supporting/life-sustaining devices may continue to be used by the end user if restored by the manufacturer to an FDA-cleared or approved version of the device. If not so restored, the manufacturer must provide updated and accurate labeling to describe product features and regulatory status (e.g., that the product lacks FDA clearance, approval, or authorization) and such devices are not to be used. A manufacturer should provide this labeling to the original purchaser and collaborate with the purchaser to ensure that labeling is distributed to other relevant stakeholders, including distributors, healthcare facilities, healthcare providers, and patients.

Alternatively, manufacturers may voluntarily withdraw their devices from the market prior to the EUA termination date. Manufacturers who do not submit a marketing submission should plan to cease all distribution by the EUA termination date. And manufacturers who submit a marketing submission but receive a negative decision from the FDA must cease distribution of their devices on the date of the decision.

Manufacturers with distinct concerns regarding the product's disposition not covered in the guidance should reach out to the FDA early on, such as through the Q-Submission Program. The FDA also advises manufacturers of medical devices authorized through EUAs to plan out their approach for when the EUA is terminated.

Specific Devices. In addition to explaining the transition policy generally applicable to all devices marketed under an EUA, the EUA Transition Plan Guidance provides additional specific recommendations for certain categories of devices.

a.    Life sustaining/supporting devices

The FDA asks manufacturers of reusable life-supporting or life-sustaining devices issued EUAs (listed in the table below) to submit an “EUA Report” informing the FDA of whether the manufacturer plans to submit a marketing submission and continue distributing their device post-EUA termination as soon as possible.

b.    Additional considerations for EUA-authorized in vitro diagnostics

For in vitro diagnostic devices (IVDs) under an EUA authorizing use in a particular setting (e.g. high or moderate complexity certified laboratory under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) or waived), the FDA intends to allow continued distribution of the tests in the authorized setting under the terms of the EUA following FDA acceptance of a marketing application. However, the FDA may object to the continued distribution of the IVD once the FDA takes a final action on the marketing submission and determines the CLIA categorization for the device. The FDA intends to make its decision on CLIA categorization under the standard processes that exist for non-EUA authorized devices. The FDA recommends that any premarketing submission that requires a CLIA categorization decision be submitted as soon as possible to ensure timely categorization.

Notably, the guidance explains that once the EUA declaration for COVID-19 IVDs terminates, the agency intends to revert to exercising enforcement discretion over laboratory-developed tests (LDTs) for COVID-19 LDTs in the same way it exercises enforcement discretion over other LDTs.

Enforcement Discretion Transition Plan Guidance
Given the large scale of the COVID-19 pandemic and the number of medical products marketed pursuant to a COVID-19-related enforcement discretion policy, the FDA published a notice in the Federal Register on March 13, 2023 grouping the corresponding guidance documents into four categories:

1. Guidance documents that will no longer be in effect when the Section 319 PHE declaration expires.
2. Guidance documents that will remain in effect for 180 days after the PHE declaration expires and then will no longer be in effect.
3. Guidance documents that will remain in effect for 180 days after the PHE declaration expires, during which time the FDA plans to further revise. 
4. Guidance documents that will remain in effect after the PHE expires.

The Enforcement Discretion Transition Plan Guidance relates to medical devices in the second category above. The FDA explained in the guidance that it will grant medical devices marketed pursuant to the policies outlined in the guidance documents in List 1 (see below) a phased transition period beyond the termination of the Section 319 PHE declaration. The transition period is to last for 180 days after the expiration of the Section 319 PHE declaration, which would fall on November 7, 2023. This means the guidance documents the FDA issued in List 1 will continue in effect until November 7, 2023.

List 1:

• Enforcement Policy for Remote Digital Pathology Devices During the COVID-19 Public Health Emergency
• Enforcement Policy for Imaging Systems During the COVID-19 Public Health Emergency
• Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the COVID-19 Public Health Emergency
• Enforcement Policy for Telethermographic Systems During the COVID-19 Public Health Emergency
• Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the COVID-19 Public Health Emergency
• Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the COVID-19 Public Health Emergency
• Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the COVID-19 Public Health Emergency
• Enforcement Policy for Infusion Pumps and Accessories During the COVID-19 Public Health Emergency
• Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the COVID-19 Public Health Emergency
• Enforcement Policy for Gowns, Other Apparel, and Gloves During the COVID-19 Public Health Emergency
• Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the COVID-19 Public Health Emergency
• Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the COVID-19 Public Health Emergency
• Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the COVID-19 Public Health Emergency
• Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the COVID-19 Public Health Emergency (Revised)
• Enforcement Policy for Viral Transport Media During the COVID-19 Public Health Emergency (Revised)

Transition Plan

The transition plan provides manufacturers of devices subject to one of the above enforcement policies the opportunity to bring the device into compliance with applicable regulations during the transition period if the manufacturer plans to continue marketing the device after the transition period ends.

The transition plan for devices described in the guidance documents in List 1 above will take place in the following three phases:
 

 
The FDA recommends that manufacturers intending to continue marketing their products after the PHE expires submit a Transition Implementation Plan addressing the plan for dealing with devices already distributed along with the applicable marketing submission. Manufacturers that receive a negative decision on their submission or that fail to provide a complete and timely response to an FDA request for additional information will be expected to discontinue distribution of the device.