January 11, 2022
The US Food and Drug Administration has published transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public health emergency but that will require full regulatory registration to remain legally commercialized.
New draft guidance from FDA cover transition plans for devices granted EUA designations during the coronavirus pandemic; the guidance provides more clarity regarding how device manufacturers whose devices were made available via pandemic-era EUAs will be affected once the public health emergency abates. Industry and other stakeholders have 90 days to comment on FDA’s approach.
Medical devices marketed under EUA designation
EUA designations now in place for medical devices that have yet to obtain 510(k) clearance or other market registration from FDA are intended to expire once the COVID-19 emergency is overcome. Once a device’s EUA designation expires, full US market registration is required in order to keep that device on the US market.
Six-month notice for EUA terminations
In its new draft guidance, FDA has clarified processes for termination and transition policies for devices granted EUA designations related to the coronavirus pandemic:
- FDA will provide an advance notice of termination for each EUA in the US Federal Register 180 days prior to an EUA’s final termination date
- FDA will not object to continued marketing of a device for which a premarket application for full US market access has been submitted to the agency by that device’s date of EUA termination
- FDA recommends that manufacturers of reusable, life-supporting and life-sustaining devices submit reports to the agency for evaluation of potential product shortages post-EUA termination
For device manufacturers not planning full FDA registration
In cases where manufacturers do not intend to continue marketing devices once their EUAs are terminated, FDA states that the agency has no plans to request or require removal of remaining supplies from the market, provided that devices meet one or more of the following conditions:
- Single-use, non-life-supporting and non-life-sustaining devices such as face masks that were distributed before their EUA termination dates and will be consumed by end users
- Reusable, non-life-supporting and non-life-sustaining devices such as remote patient monitoring devices distributed before their EUA termination dates, provided that manufacturers either restore these products to previous versions that have obtained FDA market authorization or ensure publicly available labeling regarding device features and regulatory status
- Reusable life-supporting, life-sustaining devices such as ventilators and oxygenation systems distributed before their EUA termination dates, again under the condition that manufacturers either restore these products to previous FDA-cleared or approved versions or provide labeling to address device features and regulatory status
- In vitro diagnostic (IVD) devices that had been distributed prior to their EUA termination dates and are used no later than two years following their EUA termination dates (or before their expiration dates)
Although no clear end date for the COVID-19 public health emergency has yet become apparent, FDA has now provided more concrete timelines and policies for manufacturers that intend to remain on the US market once their EUA designations expire, as well as for firms that will not.
Learn more about US FDA medical device regulations at Emergo by UL:
- FDA 510(k) premarket notification consulting for medical device and IVD manufacturers