- FDA is planning to give holders of emergency use authorizations (EUA) for COVID-19 diagnostics and devices 180 days notice of its intent to terminate their approvals.
- In a draft that addresses one of its top guidance priorities, FDA sets out the transition plan for devices authorized under an EUA. The plan is intended to avoid supply disruptions while moving back toward the regulatory requirements of routine operations.
- FDA wants to know whether the 180-day notice period is long enough to avoid "exacerbating product shortages and supply chain disruptions" and if the text fulfills its obligation to consult with EUA holders "with respect to the appropriate disposition of the product."
With FDA issuing hundreds of EUAs during the COVID-19 pandemic, the agency has turned its attention to how it will transition those products, many of which came to market with scant supporting evidence, to normal regulatory procedures. That thinking has led to the publication of draft guidance that is open for comment for 90 days.
FDA is proposing to publish notices in the Federal Register 180 days before it intends to terminate EUAs. What happens after that depends on the type of medical device covered by the EUA and whether the manufacturer plans to apply to stay on the market after the termination of the emergency authorization.
The agency is asking holders of EUAs for reusable life-supporting or life-sustaining devices, such as ventilators, to let it know whether they plan to make a marketing submission as soon as possible after the guidance is finalized. The request reflects the "public health significance" of the devices and the need for FDA to allocate resources to the review of marketing submissions.
To stay on the market after the termination date, manufacturers need to have had a marketing approval application accepted for review by FDA. That flexibility applies to all types of products covered by EUAs. The rules diverge when manufacturers opt against distributing their devices after the termination date.
In that scenario, FDA will not request market removal provided the EUA holder complies with certain requirements. Manufacturers of face masks do not need to do anything, and the only requirement for providers of in vitro diagnostics is that tests distributed prior to the EUA termination date are used within two years.
The requirements for manufacturers of products such as remote patient monitoring devices and ventilators are more involved. To avoid market removal, manufacturers must either restore the product to the previously FDA-cleared or approved version, or have labeling that states the product lacks FDA clearance or approval.
The agency's plan follows concerns regarding the safety of devices that received the EUA designation during the pandemic. Product safety watchdog ECRI has been vocal about their concerns of EUA use multiple times throughout the year.