Dr. Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health (CDRH), believes the level of flexibility shown by the FDA during the COVID-19 pandemic may be needed in a post-pandemic world.
Speaking in a town hall event at The Virtual Medtech Conference hosted by AdvaMed, Shuren outlined the work the FDA has put into emergency use authorizations (EUAs) during COVID-19 and emphasized the importance of remembering the pandemic’s impact once it ends.
“COVID-19 has presented many challenges to our country, the world and the FDA,” Shuren said. “The greatest tragedy of this pandemic would be if we did not learn from it — not just how we may be better prepared for the next outbreak, but how we can take the lessons learned to better serve patients at all times.”
The FDA has used its EUA power to authorize more than 500 medical devices since the beginning of February, authorizing (on average) one every day.
However, Shuren said he believes that the regulatory structure for medical devices is outdated and outmoded, and insisted that the FDA should use the same level of flexibility instituted by CDRH during the pandemic to tailor its processes to the technology coming through the pipeline.
“The regulatory paradigm established for medical devices is over 40 years old and is not well-suited for many modern-day technologies,” Shuren said.
The pandemic’s early weeks left some CDRH staffers overwhelmed and working shifts longer than those of medical residents, noted Dr. Binita Ashar, director of the center’s surgical and infection control devices division. While the new enforcement policies helped move things along, the challenge throughout the organization remains strong, stretching review times for premarket approvals as the backlog of submissions continues to rise.
“It’s creating stress on the system,” Shuren said. “We’re not able to handle that full workload in the way that we otherwise would be able to do. We’ve had to reprioritize our work… COVID-19 is all hands on deck.”
When asked to review the reaction of CDRH and the FDA to the pandemic and evaluate what he may do differently if given the chance to go back, Shuren complimented agency staff for their hard work.
“If I had to do it over again, I would never do it over again,” Shuren said. “Credit to the folks at CDRH… Credit, too, to the developer community who stepped up to the plate and saw the crisis in the U.S. and wanted to help out.
“All of that makes a difference. Where there’s a will, there’s a way. And there was a really strong will.”