On March 24, the agency released two final guidances — one for emergency use authorizations related to COVID-19, and another for other devices linked to the public health emergency.
Since March 2020, the FDA has issued more than 950 medical device emergency use authorizations, leading to more than 430 different medical devices that aim to diagnose, treat or prevent COVID-19, the agency said. In the final guidance, the FDA said HHS intends to publish news of EUA terminations with a notice of 180 days.
The FDA’s Center for Devices and Radiological Health said it “developed these transition guidances to help avoid disruption in device supply and facilitate compliance with applicable requirements, while providing stakeholders with recommendations and an appropriate transition period to ensure an orderly and transparent transition to normal operations.”
On March 16, the FDA updated some resupply dates on its device shortage list to predict a restock in 2023.
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