Note: This article provides information related to our 2021 Health Technology Hazard #1, Complexity of Managing Medical Devices with COVID-19 Emergency Use Authorization. We encourage readers to refer to that article for information on the steps for EUA device management that their facility should be performing.

The Biden Administration has stated its intention to end the public health and national emergency declarations related to the COVID-19 pandemic on May 11, 2023. However, this announcement does not alter the status of medical devices that have been temporarily approved for use under Emergency Use Authorizations (EUAs). As things currently stand, EUA devices may continue to be used beyond that date.

The reason for this, in short, is that although multiple emergency declarations and determinations have been made related to the COVID-19 pandemic, the ones that are ending on May 11 are not the ones that were used to authorize FDA's issuance of EUAs. Thus, the ending of those specific declarations does not terminate pandemic-related EUAs. In a frequently asked questions (FAQ) page related to the announcement, FDA states that existing EUAs for products "will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met."

To explain: The COVID-19 public health emergency was declared under Section 319 of the Public Health Service Act (42 U.S.C. § 247d), and a national emergency was declared under Section 201 of the National Emergencies Act (50 U.S.C. § 1622). However, EUAs are issued by FDA under Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. § 360bbb-3). Under the FD&C Act, three steps lead to a valid EUA:

1. A determination under the FD&C Act that a public health emergency or other specified kind of emergency exists (this determination is independent of any Public Health Service Act or National Emergencies Act declaration, like the ones noted above);

2. Based on that determination, a declaration that circumstances exist justifying authorization of emergency use; and

3. The issuance of EUAs under that declaration.

On February 4, 2020, the US Department of Health and Human Services (HHS) did issue a determination that a public health emergency existed. HHS then made multiple declarations that circumstances existed justifying the authorization of emergency use of in vitro diagnostics, personal respiratory protective devices, medical devices, and drugs and biological products, respectively. Then FDA issued individual EUAs under those declarations.

While FDA may revoke an individual EUA at any time when circumstances warrant, blanket termination of pandemic-related EUAs generally would not occur until HHS terminates one or more of the declarations under which EUAs were issued. HHS has not yet taken that action. If and when HHS does terminate a COVID-19 EUA declaration, any EUAs that were issued as a result of that declaration will cease to be in effect, and FDA may no longer issue EUAs for products covered by that declaration.

Even in that circumstance, the effect on healthcare organizations would not be immediate. HHS must give advance notice that a declaration will be terminated. The advance notice must allow enough time for disposition of either the product (for unapproved products) or the labeling or information (for unapproved uses of approved products) (21 U.S.C. § 360bbb-3[b][3]). Further, FDA has finalized a transition plan that includes 180 days' advance notice of termination for each EUA declaration pertaining to medical devices.

Keep in mind that, as noted above, FDA can revoke an individual EUA at any time if the agency determines that the circumstances justifying its issuance no longer exist, that the criteria for its issuance are no longer met, or that revocation is otherwise appropriate to protect public health or safety (21 U.S.C. § 360bbb-3[g][2]). Thus, healthcare organizations should continue to track the status of any EUA products in their inventories, as detailed in our 2021 Top 10 Health Technology Hazard article, Complexity of Managing Medical Devices with COVID-19 Emergency Use Authorization.