In early 2023, the Biden administration announced and set into motion its plans to wind down a number of pandemic-related programs and allow the COVID-19 public health emergency (PHE) declaration,^[1] which has been in effect since January 2020, to expire on May 11, 2023.^[2] As we discussed in our prior alert, the expiration of the PHE declaration marks the end of a number of US Food and Drug Administration (FDA) COVID-19-related policies that have provided regulatory flexibilities throughout the pandemic.

On March 24, 2023, the FDA’s Center for Devices and Radiological Health (CDRH) announced the issuance of two much-anticipated final guidances (collectively, the Final Transition Guidances) that describe the FDA’s transition plans for medical devices that fall within certain COVID-19 enforcement policies or were issued emergency use authorizations (EUAs):

• Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Enforcement Policies Final Guidance)
• Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) (EUA Transition Final Guidance)

Notably, devices within the scope of the Final Transition Guidances may continue to be marketed under the applicable existing enforcement policy or EUA for a period beyond May 11, 2023, as detailed in the guidances. Below we summarize some of the key takeaways from FDA’s finalized transition plans:

Scope of the Transition Plans

As previously announced by the FDA on March 13, 2023, in a notice issued in the Federal Register (and as we discussed in our prior Alert), the FDA identified 15 CDRH enforcement policy guidances as continuing to be within the scope of the Enforcement Policies Final Guidance:

The EUA Transition Final Guidance is applicable to all devices that have been issued an EUA under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on the basis of a device EUA declaration related to COVID-19. The FDA has issued more than 950 EUAs for medical devices, including 430 different medical devices to help diagnose, treat, or prevent COVID-19.

180-Day Transition Period

Both the Enforcement Policies Final Guidance and the EUA Transition Final Guidance set out a 180-day transition period.

Under the Enforcement Policies Final Guidance, the 180-day transition period begins on the “implementation date,” which will be May 11, 2023, assuming that the PHE expires on that date in accordance with the Biden administration’s current plan. The Enforcement Policies Final Guidance sets out three phases by which time various regulatory responsibilities should begin.

While the EUA Transition Final Guidance also contemplates a 180-day transition period, a beginning date to trigger the 180-day transition period has not yet been selected. The FDA’s authority to grant and maintain EUAs is distinct from and not tied to the status of the PHE declaration. Accordingly, COVID-19 EUAs may remain in effect long after May 11, 2023.

The FDA’s ability to grant and maintain EUAs depends on the status of a separate type of declaration, commonly known as an EUA declaration.^[3] Once an EUA declaration is terminated, all EUAs issued based on that declaration will cease to be in effect, and the FDA may no longer issue EUAs for products covered by that declaration. Since the beginning of the pandemic, the Health and Human Services (HHS) secretary has issued four separate EUA declarations that pertain to in vitro diagnostics, personal respiratory protective devices, other medical devices, and drugs and biological products. Each declaration functions separately and opens the EUA pathway for the specific product types described in the declarations. The HHS secretary may choose to terminate some of the declarations while leaving others open.

Prior to terminating an EUA declaration, the HHS secretary is required to provide advance notice that an EUA declaration will be terminated and publish such notice in the Federal Register. No such notice has been issued to date.

Marketing after the 180-Day Transition Period

Under the Enforcement Policies Final Guidance, at the end of the 180-day transition period (expected on November 7, 2023), the 15 CDRH enforcement policies listed above will cease to be in effect and manufacturers marketing devices pursuant to the policies will no longer be able to take advantage of the regulatory flexibilities provided by the policies.

Similarly, under the EUA Transition Final Guidance, at the end of the 180-day transition period, from the date the FDA publishes in the Federal Register advance notice of termination of an EUA declaration, the EUA declaration will be terminated and all EUAs issued based on that declaration will cease to be in effect.

Nonetheless, in both guidances, the FDA sets out an enforcement policy for devices with a marketing submission under review by the FDA. Specifically, this enforcement policy allows for the continued distribution of devices within the scope of the Final Transition Guidances when:

1. the manufacturer has submitted a marketing submission to the FDA and the submission has been accepted by the FDA prior to the end of the 180-day transition period; and 
2. the FDA has not taken a final action on the marketing submission.
   This enforcement discretion applies only to the premarket clearance or approval requirement and certain unique device identification and other applicable labeling requirements.

Preparing for the Transition

CDRH has and continues to encourage device manufacturers who plan to continue marketing their devices to prepare and submit their marketing submissions soon.

Further, the FDA encourages such device manufacturers to leverage the pre-submission process when needed in order to have early interactions with CDRH. In particular, pre-submissions may be utilized to discuss a manufacturer’s plan to leverage real-world evidence to support their marketing submission or discuss extenuating circumstances (e.g., an ongoing clinical trial or longer-term nonclinical study) that may make it difficult to submit an administratively complete marketing submission to the FDA by the end of the 180-day transition period.

The FDA also recognizes that some manufacturers may require more time to transition to a system that fully complies with the FDA’s Quality System Regulation. Such manufacturers may consider requesting an exemption or variance from a Quality System requirement, and the FDA indicates that any such exemption or variance should be requested within 90 days of the implementation date for a device subject to an enforcement policy or within 90 days of the publication of the applicable advance notice of termination of an EUA declaration for a device marketed under an EUA.

^[1] The COVID-19 PHE declaration was originally issued on January 31, 2020, and subsequently renewed by the Health and Human Services (HHS) secretary pursuant to the authority under Section 319 of the Public Health Service Act.
^[2] Separately, on April 10, 2023, President Biden signed into law H.J. Res.7, which terminates the national emergency related to the COVID-19 pandemic that was originally declared by the finding of the president on March 13, 2020. The termination of the national emergency does not affect the PHE declaration. 
^[3] EUA declarations are made by the HHS secretary pursuant to the authority under Section 564 of FD&C Act.

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