On March 24, 2023, the U.S. Food and Drug Administration (FDA) finalized two guidances for transitioning medical devices from certain policies and operations instated during the COVID-19 Public Health Emergency (PHE). The guidances provide an overview of the steps FDA recommends for companies transitioning their devices out of PHE-era policies and operations into “normal operations” once the PHE ends.  

FDA recommends companies become familiar with the guidances and develop a transition plan that addresses the steps that must be taken if they wish to continue marketing their devices in the U.S.  

EUA Medical Devices and Enforcement Policies During the PHE 

At the onset of the PHE, FDA recognized the medical device supply chain was overextended, due to high demand and low supply for certain devices.  

Because these devices intended to diagnose, treat, and prevent COVID-19 and associated conditions, FDA issued enforcement policies and Emergency Use Authorizations (EUAs) aimed at increasing availability of devices “intended to support the emergency response to the COVID-19 pandemic.”   

Examples of qualifying devices include: 

• Ventilators 
• In vitro diagnostics 
• Personal protective equipment intended for medical use 

As the end of the PHE approaches, FDA is attempting to help facilitate a smooth transition into normal regulations for these devices. The agency issued two guidances recommending transition plans for devices that: 

• Fall within certain enforcement policies issued during the PHE 
• Are under an EUA related to the PHE 

Companies currently marketing devices in one or both categories must allow ample time to prepare their devices for normal operations. Many companies will need to send in a marketing submission for their devices, which is often a lengthy process. 

FDA urges companies to get started right away by initiating a pre-submission during the transition process to prevent delays in the marketing submission process. During a pre-submission, companies meet with FDA to ask questions and get clarification about what FDA’s review of their device will entail.  

FDA then gives feedback, which companies can implement while undergoing their marketing submission, likely shortening the review process. 

Devices Under PHE Enforcement Policies  

Initially, enforcement policies set forth during the PHE were only intended to remain in place for the duration of the PHE. On March 13, 2023, FDA announced in the Federal Register that it had revised certain guidance documents to state the policies would continue for 180 following the PHEs expiration.  

FDA recommends a “phased transition process” for the transition. The guidance outlines which steps companies should take during each phase. Recommended transition phases apply to companies that are and are not seeking marketing authorization for their devices after the PHEs expiration. 

The “implementation date” is the date the PHE expires or 45 days after the guidance’s finalization, whichever is later.  

FDA’s Phased Transition Process 

FDA recommends the following phased approach:  

Phase 1: Begins on the implementation date (May 11, 2023) 

• Manufacturers begin preparing for Phase 3 by adhering to adverse event reporting requirements (21 CFR Part 803) 

Phase 2: Begins 90 days after the implementation date (August 9, 2023) 

• Manufacturers follow reports of corrections and removals requirements (21 CFR Part 806) and registration and listing requirements (21 CFR Part 807 Subparts B-D)  
• Registration and listing requirements only need to be followed for companies continuing to distribute their devices after Phase 2 

Phase 3: Begins 180 days after the implementation date (November 7, 2023) 

• Certain guidances will no longer be in effect. Companies that have submitted a required marketing submission for a device can continue distributing the device if FDA has accepted the submission before Phase 3 starts, even if FDA has not taken final action on the submission.  

While devices are under FDA review, FDA does not intend to object to devices that do not comply with certain labeling and Unique Device Identification (UDI) requirements. However, these devices must comply with other requirements, including registration and listing. 

EUA Devices 

For EUA devices, FDA doesn’t include phases in the transition, but “instead relies on the advance notice(s) of termination process required under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).”  

In the guidance for EUA medical devices, FDA is requesting that manufacturers of certain reusable life-supporting or life-sustaining devices that have been issued an EUA provide a Notification of Intent to FDA. The notification informs FDA whether the manufacturer will pursue a marketing submission after the EUA is terminated.  

While a device is under review, FDA does not intend to object to the absence of a Unique Device Identification (UDI) or failure to comply with other labeling requirements if the device continues to bear labeling previously authorized under the EUA. 

The following hypotheticals illustrate how the transitioning process could occur:

Example	During the transition		After the EUA termination
Single-use surgical mask not being marketing after EUA termination	Manufacturer continues to distribute masks and comply with regulations		Distribution ceases Distributed masks can be used by expiration date The manufacturer must submit adverse event reports
Continuous ventilator not being marketing after EUA termination	Manufacturer submits a Notification of Intent to FDA stating it will not pursue marketing authorization		Already-distributed ventilators cannot be used
Continuous ventilator being marketing after EUA termination	Manufacturer submits a Notification of Intent to FDA stating it will pursue marketing authorization Manufacturer submits marketing submission. The submission is not accepted due to deficiencies Manufacturer corrects deficiencies, and FDA accepts submission		If FDA has accepted the device for review by the EUA termination, distribution can continue Positive Decision Made: Manufacturer begins Transition Implementation Plan
Molecular diagnostic test kit being marketing after EUA termination	Manufacturer submits a Notification of Intent to FDA stating it will pursue marketing authorization Manufacturer submits marketing submission FDA accepts submission		Manufacturer begins Transition Implementation Plan    If Negative Decision: Recall of products if found unsafe If not subject to recall, distributed devices can be used by expiration date

This illustration provides a brief summary of the steps involved in the transition. There will be additional steps and nuances, which will vary by circumstance.  

Manufacturers wishing to pursue a marketing submission should begin now so there is enough time for FDA to accept the submission. If there are issues that could delay the submission, such as ongoing clinical trials, the submitter should communicate with FDA early in the transition. 

Start Preparing Your Medical Device Today 

All companies that manufactured a medical device under the authorization of an EUA or PHE enforcement policies should prepare now for the transition to normal operations.  

Because many manufacturers are currently marketing devices that do not comply with standard FDA regulations for medical devices, it could take several months to adjust processes so that devices can continue to be distributed in the U.S.  

If your medical device requires a marketing submission, now is the time to prepare. Waiting too long may cause delays in the marketing submission process and result in your device falling out of compliance and becoming unmarketable.  

Registrar Corp’s team of regulatory experts can guide you through FDA’s shifting requirements for these medical devices so that you can make a smooth and informed transition to post-PHE regulatory policies