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How FDA Ramped up Medical Device Reviews

Agency leaders helped lead FDA’s COVID-19 emergency response and improved processes to expedite delivery of critical medical supplies.

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Following the onset of COVID-19, one office within the Food and Drug Administration leveraged new processes and developed innovative tools to support increased public health demands in regulating medical devices, leaders explained during FDA’s regulatory conference with industry this month.

Like other FDA offices, emergency use authorizations enabled the Center for Devices and Radiological Health (CDRH) to expedite consumer access to new medical devices like personal protective equipment, said the organization’s director, Dr. Jeff Shuren. Since the start of the pandemic, personal protective equipment alone contributed to a 38% increase in premarket submissions.

“CDRH took advantage of that EUA authority and participated in extensive engagement with product developers to help bring to market scores of medical devices. We also took active steps to mitigate supply chain shortages,” Shuren said.

Over the past year and a half, CDRH authorized nearly 1,400 COVID-19 medical devices and expanded COVID-19 tests to include molecular diagnostics tests, antigen diagnostics tests and serology and other immune response tests.

“We also issued several guidance documents that provided flexible policies to all other types of medical devices needed for COVID-19 to come to market more expeditiously, as well as to allow a variety of kinds of devices that had already received full marketing authorization to make certain types of modifications without the need for prior FDA review,” Shuren said.

As CDRH is continuing to evaluate new solutions at a faster rate than before the pandemic, the center’s leaders are looking at new ways to better assess these technologies and get them to market as quickly as possible.

Edward Margerrison, director of the Office of Science and Engineering Laboratories (OSEL) with CDRH, said that his team is working to keep pace with novel technology and ensure the workforce understands these solutions, so that when innovative devices come to FDA, they can be put to market sooner.

One example would be augmented or virtual reality. Because this technology was historically developed and applied in different applications, like gaming, CDRH has to determine if it is up to the medical standard for the marketplace.

“We want to increase the chances of success for all of these technologies. Sometimes these technologies fail just because they don’t work for a scientific reason. One of the things we’re trying to avoid at all costs is that a technology will fail because it doesn’t have an appropriate testing methodology. That’s where we’re trying to make our science much more publicly available and in a more usable format,” Margerrison said.

To improve the review process, CDRH is developing new regulatory science tools to create a standardized device testing methodology into the public domain as early as possible. CDRH is currently focusing on helping early-stage development companies and innovators progress technology in a meaningful way.

“We’re trying to reduce the burden at all parts of the total product lifecycle. My particular focus is trying to alleviate some of that work burden at the very far upstream to allow innovators to concentrate on their innovating and focus on technology and products, and not have to necessarily develop standards and tools for evaluating,” Margerrison said.

From the pandemic, CDRH took lessons learned to be applied to the next public health crisis. Shuren said that throughout the pandemic, CDRH tailored its oversight to facilitate the availability of critical devices, engaged with clinical and technology experts and increased flexibility to push new offerings to market.

“The combination of regulatory flexibility and engagement was really the ‘secret sauce’ that allowed us to authorize so many medical devices during COVID-19,” Shuren said.

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