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An EUA (Emergency Use Authorization) was, until recently, rarely given. With the start of the COVID-19 pandemic, many new pharmaceuticals and medical devices received EUAs in order to help combat the pandemic. On top of vaccines, many medical devices, such as ventilators, patient monitoring devices, and infusion pumps, received EUAs.[1] While an EUA provides great aid to public health it does not last forever and if the manufacture wishes to keep their product on the market then compliance with FDA regulations is still necessary.

              Manufacturers should be aware of the necessary steps to achieve FDA approval once the EUA inevitably ends. If the FDA does not approve the product before the end of the EUA then the product will need to be potentially recalled. Generally, an EUA lasts as long as the public health emergency does.  It is possible to receive FDA approval before the EUA ends, this way there is no issue with the product being on the market once the emergency is declared over.

Depending on the type of product being manufactured there are multiple pathways that can be taken. For medical devices, such as ventilators, the 510(k) pathway will be the one most often used. The 510(k) pathway is used for devices that there is already a predicate device for on the market. This is as opposed to the De Novo pathway which is undergone when the device is entirely new.

On the other hand, for pharmaceuticals and other drugs, a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) would be needed. For drugs that have a monograph available and are over the counter (OTC) the OTC drug monograph path is also an option. Meeting the quality and compliance standards set by the FDA can be tough. EMMA International can help prepare for FDA approval following any of the pathways above and more. From developing a quality management system to assisting with regulatory submissions, EMMA can help bring your medical product from concept to commercialization. Give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (September 2021) Emergency Use Authorization retrieved on 10/5/2021 from: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#vaccines

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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