The Regulatory Impact of EUAs

Emergency Use Authorization (EUA) is a valuable asset that the FDA uses to make exceptions for unapproved medical devices during public health crises. While it has brought up some controversy since COVID-19 started making its way around the globe, there is little doubt that it has had a major impact on the regulatory policies of industries everywhere. EUAs are affecting more industries than just the medical device manufacturers. They’re also playing a role in speeding up approvals for other manufactured products.

 

How Manufacturers Are Using EUA Authority

Since February 2020, the FDA has issued EUAs for more than 100 different elements, such as drugs, devices and biologics. Simultaneously, many other organizations — such as those that make personal protective equipment, ventilators and hand sanitizers — have gone through the EUA process for distribution approval.

 

Over the last few months, hand sanitizer has flown off the shelves due to the increase in COVID-19 fears. Doctors have become desperate for PPE and respirators as patients enter hospitals in critical condition from the illness. Manufacturers that produce these types of products want to make sure their goods reach the market faster so that individuals and doctors can start reaping the benefits right away. As a result, they’re using EUA to skip over the lengthy 510(k) submission processes.

 

While this strategy can help manufacturers turn out new products more quickly, what happens after the emergency has passed? If you work in one of these industries, how will you keep these products on the market over the long term?

 

What You Need to Know

Receiving EUA approval provides a faster way for manufacturers to put their products on the shelves, even if those products are still in the experimental phase. The regulatory impact of EUA approval during COVID-19 is that more products are receiving fast approval than ever before. That said, it’s crucial to remember that this approval is only temporary.

 

The government needs to declare a state of defense or public health emergency before an EUA can be issued for a product. After the emergency passes, you’ll have to go through the traditional approval process to ensure that your product is effective and safe to use.

 

Now that the COVID-19 quarantine has become more relaxed, you need to start considering long-term strategies if you want your product to stay on the market. Preparation is an essential part of bringing products onto the market and maintaining a consistent supply chain flow. To have a product authorized, you may need to start gathering relevant information and resources, such as test data, labeling requirements and clinical support. Going through the full approval process will ensure that your product is fit to serve the public on a long-term basis.

 

Learn More From Regulatory Compliance Associates

COVID-19 has changed the way manufacturers across the U.S. manage regulatory laws. At Regulatory Compliance Associates Inc., we can help you learn more about crucial industry standards you’ll need to follow to receive ongoing approval. Contact us to get started.

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