The director of the FDA’s Center for Devices and Radiological Health says the regulatory structure for medical devices needs to change and adapt with lessons learned from the COVID-19 pandemic, reports Medical Design & Outsourcing.
“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However, Shuren said he believes that the regulatory structure for medical devices is outdated and outmoded, and insisted that the FDA should use the same level of flexibility instituted by CDRH during the pandemic to tailor its processes to the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.
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