The sudden, brutal onset of the coronavirus pandemic in 2020 created an immediate, pressing need for new products and technologies to treat victims, prevent infection, and protect our health care workers. Although many countries had pandemic preparedness plans in place before COVID-19, few were truly ready for the speed and indiscriminate spread of the disease.

While innovation and collaboration increased during the pandemic, so too did supply chain disruptions and workforce shortages. No one can forget the challenges triggered by an escalating demand for personal protective equipment (PPE) and other essential medical supplies. Haunting images were everywhere, showing doctors and nurses with painful red marks on their faces from reusing masks while performing their heroic duties. The need for more diagnostic tests hampered early efforts to curb the virus’s spread, and scientists raced to find a vaccine to prevent further deaths and severe illness. Meanwhile, in crowded ICUs, doctors had to make heartbreaking choices about allocating ventilators to critically ill patients who far outnumbered the devices available.

COVID-19 Medical Device Emergency Regulations

As COVID-19 made its first lethal surge across America, the secretary of the U.S. Department of Health and Human Services (HHS) declared, pursuant to the Federal Food, Drug, and Cosmetic (FD&C) Act, that this was a public health emergency that could jeopardize national security and the health and well-being of citizens traveling abroad. This allowed the federal government to authorize emergency-use in vitro products to detect or diagnose COVID-19, personal respiratory protective devices, and other medical devices (including alternative products used as medical devices). This was permitted under section 564 of the FD&C Act and subject to the terms of any authorization issued under that section. 

Consequently, the FDA issued emergency use authorization (EUA) letters that allowed for the expedited commercialization of test kits, PPE, and ventilators through several mechanisms. This included waiving 510(k) requirements, current good manufacturing practice (CGMP) rules, and establishment registration and device listing guidelines for new facilities and devices. 

The renewed supply of COVID-related medical devices gave us hope by facilitating more patient care options and better protection for medical personnel. Crucially, it made the vaccine’s rapid development possible, and by the end of 2020, frontline health care workers were receiving the first doses. 

What Do Regulatory Changes Mean for the Future of Medical Device Manufacturing?

To meet the heightened demand for much-needed medical devices, industry regulators worldwide have adapted their approaches to granting market approval. These changes have significant implications for the future of medical device regulation. To market or sell a new medical device legally in the U.S., you must get either FDA approval or clearance, depending on the product’s classification, which can be challenging.

What is the difference between FDA clearance and FDA approval

Most people use “approval” and “clearance” interchangeably, but the terms apply to specific regulatory submission routes the FDA uses to ensure the safety and efficacy of medical device products. Understanding the distinctions is vital to streamlining FDA inspection processes and avoiding potential legal and public health consequences.

FDA approval is usually mandatory to market or sell products that can benefit your health but might present significant risks of injury or illness. These products can range from prescription and over-the-counter medications to vaccines and Class III medical devices. According to the FDA, Class III products “usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.”

FDA clearance is a much lower bar to clear, applying mainly to Class I and II devices that pose less-severe risks to health and safety. This category encompasses PPE worn by health care workers and others who may be in danger of infection from viral and bacterial contaminants. The essential nature of Class II PPE, such as N95 respirators and home-use ventilators, became starkly clear to us once COVID-19 struck. And, as new, more transmissible variations of the virus continue to emerge, the need for copious supplies is unlikely to diminish anytime soon.

It’s important to note that, according to the FDA, “when an EUA for a device is no longer in effect, the device may no longer be legally marketed unless it has received marketing authorization from the FDA. Manufacturers are encouraged to pursue premarket submissions through the appropriate regulatory pathway (for example, 510(k), De Novo request, PMA) during the public health emergency so that devices authorized under an EUA can remain on the market after the EUA is no longer in effect.” 

While there has been some relaxation of regulatory requirements, demonstrating that minimum specifications for products have been met will continue to be a critical part of regulatory assessments. Medical device innovators must meet top quality standards and regulations for these reasons. To do this, you should engage the services of a medical device contract manufacturing company you can trust.

Let Pathway NPI Optimize Your Medical Device Strategy

Do you need help understanding your regulatory responsibilities? Or perhaps you need end-to-end assistance navigating the complex landscape of medical device design, development, and production? Contact us today for an initial consultation!