U.S. Emergency Use Authorization (EUA)
In the United States, Emergency Use Authorizations (EUAs) may be granted by the Food and Drug Administration (FDA) for certain drugs or medical devices to help strengthen the nation against health threats such as infectious diseases like COVID-19. EUA’s temporarily authorize previously unapproved medical products, or unapproved uses of approved medical products, to be used to help prevent, diagnose, or treat diseases or conditions caused by the public health emergency.
With an EUA, a device manufacturer is granted temporary market authorization during a public health threat. However, once the public health crisis is no longer at a critical level, FDA may expire the EUA and market authorization will be revoked. Companies that intends to keep their medical device on the market after the EUA has expired will need a 510(k) pre-market notification application to be granted for their product.
Our team of regulatory experts specialize in working collaboratively with our clients to achieve their unique short-term and long-term goals in the medical device industry. Contact us today to discuss how we can not only manage your short-term EUA submission but develop your EUA in a way that will better prepare you for a 510(k) application in the future.
US Emergency Use Authorization (EUA)
In the United States, Emergency Use Authorizations (EUAs) may be granted by the Food and Drug Administration (FDA) for certain drugs or medical devices to help strengthen the nation against health threats such as infectious diseases like COVID-19. EUA’s temporarily authorize previously unapproved medical products, or unapproved uses of approved medical products, to be used to help prevent, diagnose, or treat diseases or conditions caused by the public health emergency.
With an EUA, a device manufacturer is granted temporary market authorization during a public health threat. However, once the public health crisis is no longer at a critical level, FDA may expire the EUA and market authorization will be revoked. Companies that intends to keep their medical device on the market after the EUA has expired will need a 510(k) pre-market notification application to be granted for their product.
Our team of regulatory experts specialize in working collaboratively with our clients to achieve their unique short-term and long-term goals in the medical device industry. Contact us today to discuss how we can not only manage your short-term EUA submission but develop your EUA in a way that will better prepare you for a 510(k) application in the future.
EUA Preparation and Submission Services
Post EUA Submission Support: Premarket Notification 510(k)
EUA Preparation and Submission Services
If you are looking to gain market authorization for your medical device under the EUA pathway, we’re here to help. Our team of regulatory experts will review your medical device and intended use to determine if an EUA is appropriate and applicable to your product. If so, we will work collaboratively with your team to review your product’s information, conduct a gap analysis on your available test data (analytical and/or clinical, etc.), and develop a customized submission strategy to efficiently gain authorization for your product through this pathway. If your device does not meet the EUA criteria, our team will work with you to achieve market authorization through an appropriate pathway.
Post EUA Submission Support: Premarket Notification 510(k)
With the continued decrease in COVID-19 cases over recent months, the FDA has begun revising their guidance and reducing the EUA scope for COVID-19 related devices. Companies currently marketing COVID-19 related medical devices under an EUA will need to work quickly to comply with all regulatory requirements for 510(k) premarket notification submissions if they intend on continuing commercialization following the conclusion of their EUA. At Accorto, we will develop a bespoke post-EUA submission strategy to achieve and maintain long-term market authorization for your in vitro diagnostic devices, personal protective equipment, and respiratory assistance devices, far beyond the COVID-19 pandemic.
EUA Preparation and Submission Services
If you are looking to gain market authorization for your medical device under the EUA pathway, we’re here to help. Our team of regulatory experts will review your medical device and intended use to determine if an EUA is appropriate and applicable to your product. If so, we will work collaboratively with your team to review your product’s information, conduct a gap analysis on your available test data (analytical and/or clinical, etc.), and develop a customized submission strategy to efficiently gain authorization for your product through this pathway. If your device does not meet the EUA criteria, our team will work with you to achieve market authorization through an appropriate pathway.
Post EUA Submission Support: Premarket Notification 510(k)
With the continued decrease in COVID-19 cases over recent months, the FDA has begun revising their guidance and reducing the EUA scope for COVID-19 related devices. Companies currently marketing COVID-19 related medical devices under an EUA will need to work quickly to comply with all regulatory requirements for 510(k) premarket notification submissions if they intend on continuing commercialization following the conclusion of their EUA. At Accorto, we will develop a bespoke post-EUA submission strategy to achieve and maintain long-term market authorization for your in vitro diagnostic devices, personal protective equipment, and respiratory assistance devices, far beyond the COVID-19 pandemic.
