Emergency Use Authorizations

Like many industries, COVID-19 has had a significant impact on the medical device industry. But the most notable impact it has had is with government bodies, specifically regarding regulation and emergency authorization of medical devices.

The FDA has issued what is known as a EUA–an emergency use authorization for PPE (personal protective equipment) and IVD test kits for diagnosing COVID-19. Under this declaration, the FDA has been able to rapidly authorize specific medical devices for emergency uses, as the rise of COID-19 continues to stretch our healthcare thin.

The EUA submission has still taken emergency approval cautiously. The major difference is obtaining authorization has been expedited to levels not seen before. While manufacturers may be creating devices to help combat and treat COVID-19, many of these authorizations may only remain temporary. In other words, the FDA approvals may only last as long as the public health emergency lasts, which brings uncertainty for many devices that were created for emergency use.

The Impact on Supply Chains

The FDA has already begun collaborating with many manufacturers, specifically manufacturers of ventilators and ventilator accessories. This is, in part, to help prevent future shortages of these medical devices.

The FDA has also issued final guidance on ventilators that are designed to specifically treat patients with severe COVID-19 complications. This has allowed traditionally non-medical manufacturers to enter the medical device industry, despite never having developed products for treating patients. Automotive and other industrial manufacturers have all been involved in the creation of medical devices, however, they are still being held up to the standards that the FDA requires for medical products.

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