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Glossary Term
Emergency Use Authorization (EAU)
Definition
Emergency Use Authorization (EUA) is a regulatory mechanism that allows the use of unapproved medical products or unapproved uses of approved products during public health emergencies. Issued by regulatory agencies like the FDA, an EUA expedites the availability of medical devices, diagnostics, drugs, or vaccines when no adequate, approved, and available alternatives exist to address the emergency.
Relevance to the MedTech Industry
EUAs provide a pathway for rapid deployment of medical innovations to address urgent public health needs. For medical device manufacturers, an EUA enables swift access to the market, allowing life-saving technologies to be used during critical situations like pandemics, bioterrorism, or natural disasters.
Additional Information & Related Terms
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