“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…”
“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…” Read the full article here.
Source: How FDA Ramped up Medical Device Reviews – By Sarah Sybert, July 29, 2021. GovernmentCIO.
