On December 31st, 2021, the US Food and Drug Administration (FDA) published the draft of new guidance that outlines the transition plan for devices granted and marketed in USA under EUA designation during the coronavirus pandemic.
The transition plan requires manufacturers of medical devices and IVDs, currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public health emergency, to register their devices with FDA to be able to remain legally commercialized in USA.
Although FDA didn’t communicate yet, the end date for the COVID-19 public health emergency, but manufacturers should start preparing for their transition plan as early as possible if they plan to keep selling their devices in US market.
FDA 180-days’ Notice to Medical Device Manufacturers for EUA terminations.
According to the draft guidance, FDA will be sending manufacturers 180-days’ notice of termination of their EUA prior to their EUA’s final termination date.
FDA expects manufacturers to discontinue the distribution of their medical devices in US market if:
- 1) On the EUA termination date, they haven’t submitted the required marketing submissions for their devices and didn’t receive FDA approval before the EUA termination date; or
- On the date the manufacturer receives a negative decision on their marketing submission as FDA’s final action, or on the date manufacturers withdraw their submissions or fails to provide a complete response to an FDA request for additional information within the time identified in FDA’s letter.
Notifications of Intent” for Certain Reusable Life-Supporting or Life-Sustaining Devices
Given the public health significance of certain reusable life-supporting or life-sustaining devices that have been issued an EUA, FDA recommends that manufacturers of such devices submit to FDA information regarding whether or not they intend to submit a marketing submission to continue distributing their product after the EUA termination date. This information will assist the Agency in resource planning for marketing submission review and providing increased support to manufacturers. This request applies to the following EUA-authorized devices:
21 CFR 868.5160
Generator, oxygen, portable
21 CFR 868.5440
Humidifier, Respiratory Gas, (Direct Patient Interface)
21 CFR 868.5450
High flow/high velocity humidified oxygen delivery device
21 CFR 868.5454
Ventilator, Continuous, Facility Use
21 CFR 868.5895
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Continuous, ventilator, home use
Ventilator, continuous, non-life- supporting
Ventilator, Emergency, Powered (Resuscitator)
21 CFR 868.5925
Tubing Connector for Co-venting
No corresponding CFR section
Removal of Medical Device from US Market after EUA Termination
FDA states that the agency has no plans to request or require removal of remaining supplies from the US 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 devices (IVD) that had been distributed prior to their EUA termination dates and are used no later than two years following their EUA termination dates.
GRP services for Medical Devices in USA:
Contact us, to learn more how GRP can help you register your medical devices that are under EUA before receiving FDA notice termination.
- Regulatory affairs consulting for medical devices and IVDs.
- FDA 510(k) premarket notification for medical device and IVDs.
- FDA PMA premarket application for medical device and IVDs.
- FDA IDE for investigational medical devices and IVDs.
- FDA QMS implementation and inspection.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.