April 17, 2023
Devices that received emergency use authorizations will have 180 days to transition
During the pandemic, over 4,000 medical devices that could aid in the diagnosis, treatment, and prevention of COVID-19 received emergency use authorizations (EUAs) or enforcement discretion from the Food and Drug Administration. Now, FDA has released guidance for its 180-day transition plans to help medical device manufacturers prepare for the transition from EUAs to formal clearance or approval.
The new guidance notes that, "[given] the magnitude of the response to the COVID-19 pandemic, including the number of devices issued EUAs, FDA recognizes that stakeholders may need time to adjust after the termination of the device EUA declarations to help ensure an orderly and transparent transition to normal operations."
Since a vast range of devices (infusion pumps, blood purification devices, ventilators, in vitro diagnostics, wearables, decontamination systems, etc.), received EUA authorization over the past three years, each device category could receive a separate 180-day timeline for transition, triggered by Federal Register publication of the termination of a particular EUA declaration. That means medical device manufacturers should pay close attention to the scope of each category of termination notification to see whether a particular device is affected.
FDA hosted a webinar to discuss the EUA Transition Plan as well as the closely related Enforcement Policy Transition Plan Tuesday, April 18. A town hall meeting discussing the two documents with an in vitro diagnostics slant is planned for on Wednesday, April 26, 2023, at 12:05 p.m. EST.
Deadlines for medical device manufacturers who seek to continue device marketing
Medical device manufacturers who seek to market a product currently authorized under an EUA after it expires will need their FDA marketing submission accepted for review by the time the EUA declaration is terminated in most cases. Under the EUA Transition Plan, so long as the application has been accepted for review before the EUA termination date, the manufacturer can continue to distribute the device until FDA takes final action on the application.
For manufacturers who do not intend to continue distribution of devices after the relevant EUA declaration, FDA has clarified that, for many devices, it will not request market removals of devices that have already been distributed. In addition, throughout its transition plan, FDA emphasized the agency's authority to make case-by-case decisions, regarding specific devices or device types in response to particular circumstances.
Manufacturers who intend to continue to distribute devices after the EUA expiration date will want to evaluate the timelines associated with preparation and submission of an application immediately. Compliance with regulations that were not enforced during the public health emergency, including aspects of labeling and quality management systems, may require long lead times. If manufacturers intend to include improvements or changes to devices in their applications, they may also want to consider clinical testing needs, associated timelines, and the use of real-world evidence.
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