FDA’s Emergency Use Authorization is Coming to an End. Are you Ready?
Time is running out! The Emergency Use Authorization time is ending and if you don’t act quickly you may have to pull your device from the market.
The FDA issued Emergency Use Authorizations, (EUAs) beginning in 2020, to help increase the availability of ventilators and ventilator accessories, necessary to treat patients during the COVID-19 pandemic. New FDA draft guidance, issued in December 2021, outline transition plans for devices granted EUA’s when clearances are terminated. A second guidance speaks to devices subject to FDA COVID enforcement policies.
In this session we will explain FDA’s draft guidance, the timetable and the steps companies will need to take to continue to keep their devices on the market. We will outline what anticipated return to normal operations will look like. Companies will need to determine whether they intend to cease distribution, remove existing devices, or move forward to meet FDA requirements.
In this session you will learn:
- What will marketing submissions require for devices distributed after EUA termination date?
- What is the transition plan for medical devices that fall within enforcement policies issued during the pandemic emergency
- What does a Notification of Intent look like and what elements must be included
- How to proceed if a manufacturer does not intend to continue to distribute after EUA termination
- What are the pathways available to device manufacturers following termination of an EUA